Z-0863-2018Class II
LASEREDGE Knives, CLEAR CORNEAL ANGLED 2.855MM GUARDED (6/BOX), REF/PRODUCT CODE E7528G, STERILE, Rx Only
Bausch & Lomb Incorporated / initiated 2017-03-03 / Terminated / root cause: manufacturing process
Bausch & Lomb Inc Irb began a recall of LASEREDGE Knives, CLEAR CORNEAL ANGLED 2.855MM GUARDED (6/BOX), REF/PRODUCT CODE E7528G, STERILE, Rx Only Product Usage: The LaserEdge Knives are intended for... on . FDA classified it as Class II and gives the reason as "The complaints database was reviewed and there have been an atypical volume of dull blades complaints for various lots. out of an abundance of precaution, Bausch + Lomb is voluntarily recalling all product codes SKU...". As of , the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.
Recall record
- Recall number
- Z-0863-2018
- Classification
- Class II
- Status
- Terminated
- Initiated
- Posted
- Terminated
- Recalling firm
- Bausch & Lomb Incorporated
- Product
- LASEREDGE Knives, CLEAR CORNEAL ANGLED 2.855MM GUARDED (6/BOX), REF/PRODUCT CODE E7528G, STERILE, Rx Only Product Usage: The LaserEdge Knives are intended for ophthalmic surgery. There is no therapeutic use and they are available to surgeons for use in procedures.
- Product code
- HNN Knife, Ophthalmic
- Reason for recall
- The complaints database was reviewed and there have been an atypical volume of dull blades complaints for various lots. out of an abundance of precaution, Bausch + Lomb is voluntarily recalling all product codes SKU manufacturing without the electro-polish control and penetration force testing.
- Root cause tag
- manufacturing process
- FDA root cause
- Process design
- Action
- On March 3, 2017 Bausch + Lomb , distributed Urgent Medical Device Recall notices and Acknowledgement Forms to customers via FedEx. Customers were advised to: 1. Please review your inventory and quarantine all unused (full and partial) boxes of LaserEdge" knives (6/Box or individual packaged knives) affected lots. 2. Complete the enclosed Medical Device Voluntary Recall Acknowledgement Form and contact Bausch + Lomb to obtain a Return Material Authorization Number (RMA) and arrange for a pickup of the identified product. You can contact the Bausch + Lomb Surgical Customer Service team by calling 1-800-338-2020, Customer Service (option 2), Product Returns and Adverse Event Reporting (option 2). Please contact the Bausch + Lomb Surgical Customer Service team with any questions or concerns regarding this process: 1-800-338-2020.
- Quantity in commerce
- 1,236,749 knives in total
- Distribution
- US Nationwide Distribution
- Product codes and lots
- none
Enforcement reports
One row per recalled product line| Recall number | Class | Status | Voluntary or mandated | Report date | Classified |
|---|---|---|---|---|---|
| Z-0851-2018 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0852-2018 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0853-2018 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0854-2018 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0855-2018 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0856-2018 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0857-2018 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0858-2018 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0859-2018 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0860-2018 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0861-2018 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0862-2018 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0863-2018 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0864-2018 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0865-2018 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0866-2018 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0867-2018 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0868-2018 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0869-2018 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0870-2018 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0871-2018 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0872-2018 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0873-2018 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0874-2018 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0875-2018 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0876-2018 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0877-2018 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0878-2018 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0879-2018 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0880-2018 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0881-2018 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0882-2018 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0883-2018 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0884-2018 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0885-2018 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0886-2018 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0887-2018 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0888-2018 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0889-2018 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0890-2018 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0891-2018 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0892-2018 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0893-2018 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0894-2018 | Class II | Terminated | Voluntary: Firm initiated |
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