Z-2672-2024Class II
Product Name: 25+ TOTALPLUSr CP PAK 20K CPM BWV .9 IU Model/Catalog Number: 8065000093 Software Version: N/A...
Alcon Laboratories / initiated 2024-07-15 / Open, Classified / root cause: manufacturing process
Alcon Research LLC began a recall of Product Name: 25+ TOTALPLUSr CP PAK 20K CPM BWV .9 IU Model/Catalog Number: 8065000093 Software Version: N/A Component: N/A on . FDA classified it as Class II and gives the reason as "Alcon has detected an increase in complaint reports related to sharpness for specific ClearCut Dual Bevel Sideport and A-OK Comeal/Scleral V-Lance Ophthalmic knives". As of , the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.
Recall record
- Recall number
- Z-2672-2024
- Classification
- Class II
- Status
- Open, Classified
- Initiated
- Posted
- Recalling firm
- Alcon Laboratories
- Product
- Product Name: 25+ TOTALPLUSr CP PAK 20K CPM BWV .9 IU Model/Catalog Number: 8065000093 Software Version: N/A Component: N/A
- Product code
- HQC Unit, Phacofragmentation
- Reason for recall
- Alcon has detected an increase in complaint reports related to sharpness for specific ClearCut Dual Bevel Sideport and A-OK Comeal/Scleral V-Lance Ophthalmic knives.
- Root cause tag
- manufacturing process
- FDA root cause
- Process control
- Action
- On July 15, 2024, URGENT: MEDICAL DEVICE FIELD CORRECTION letters were sent to customers. Actions to be taken by the Customer / User: Our records indicate that you have received affected sterile standalone knives/trocar entry systems, Vitrectomy/Combined Procedure Pak, or an Alcon Custom Pak with an affected knives/trocar entry system lot number. 1. If you received sterile standalone knives or trocar entry system, we are asking that you dispose of the affected ophthalmic knife/trocar entry system and use a replacement. Alcon is sending sufficient replacement quantities to cover your estimated remaining impacted inventory. 2. If you received a Vitrectomy/Combined Procedure Pak with affected trocar entry system lot numbers, we are asking that, upon opening your Vitrectomy/Combined Procedure Pak for surgical use, you remove and dispose of the affected trocar entry system and use a replacement trocar entry system. Alcon is sending sufficient replacement quantities to cover your estimated remaining impacted inventory. 3. If you received an Alcon Custom Pak with affected knife or trocar entry system lot numbers, we are asking that, upon opening your Custom Pak for surgical use, you remove and dispose of the affected knife or trocar entry system contained within your specific lot(s) of Alcon Custom Pak and use a replacement knife or trocar entry system. If you have a Custom Pak lot listed in Appendix 1, then one or two of the knives/trocar entry systems in your Custom Pak may be affected by the field correction. Please refer to the impacted lot list in Appendix 1 to ensure that the appropriate knife/trocar entry system is removed. Alcon is sending replacement quantities of knives and/or trocar entry system to cover your estimated remaining impacted inventory, and any future shipments of impacted Custom Pak lots. NOTE: Alcon surgical products are sterile and should not be opened before surgery. The remaining components of the Alcon Custom Pak are unaffected by thi
- Quantity in commerce
- 1,061 units
- Distribution
- Domestic: Nationwide Distribution Countries Affected: Argentina, Australia, Austria, Belgium, Brazil, Canada, Chile, China, Colombia, Croatia, Czech Republic, Denmark, Ecuador, Emirates, Finland, France, Germany, Greece, Hong Kong, Hungary, India, Ireland, Italy, Japan, Korea, Kosovo, Luxemburg, Malaysia, Mexico, Netherlands, New Zealand, Norway, Panama, Peru, Philippines, Poland, Portugal, Puerto Rico, Romania, Russia, Singapore, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, UK, Ukraine, Uruguay, USA
- Product codes and lots
- Model/Catalog Number: 8065000093; UDI-DI: 380650000934; Lot numbers: 16HY6X.
Enforcement reports
One row per recalled product line| Recall number | Class | Status | Voluntary or mandated | Report date | Classified |
|---|---|---|---|---|---|
| Z-2645-2024 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2646-2024 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2647-2024 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2648-2024 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2649-2024 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2650-2024 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2651-2024 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2652-2024 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2653-2024 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2654-2024 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2655-2024 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2656-2024 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2657-2024 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2658-2024 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2659-2024 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2660-2024 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2661-2024 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2662-2024 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2663-2024 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2664-2024 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2665-2024 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2666-2024 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2667-2024 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2668-2024 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2669-2024 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2670-2024 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2671-2024 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2672-2024 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2673-2024 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2674-2024 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2675-2024 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2676-2024 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2677-2024 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2678-2024 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2679-2024 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2680-2024 | Class II | Ongoing | Voluntary: Firm initiated |
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