Z-0986-2018Class II
Alden HP59 Sphere Daily Wear Soft contact; Catalog Number: AOHPS59
Bausch & Lomb Incorporated / initiated 2017-11-03 / Terminated / root cause: manufacturing process
Alden Optical began a recall of Alden HP59 Sphere Daily Wear Soft contact; Catalog Number: AOHPS59 Product Usage: The ALDEN SPHERE LENS for daily wear is indicated for the correction of... on . FDA classified it as Class II and gives the reason as "Contact lenses lack sterility assurance". As of , the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.
Recall record
- Recall number
- Z-0986-2018
- Classification
- Class II
- Status
- Terminated
- Initiated
- Posted
- Terminated
- Recalling firm
- Bausch & Lomb Incorporated
- Product
- Alden HP59 Sphere Daily Wear Soft contact; Catalog Number: AOHPS59 Product Usage: The ALDEN SPHERE LENS for daily wear is indicated for the correction of visual acuity in aphakic and not aphakic persons with non-diseased eyes with refractive ametropia (myopia or hyperopia). The lens may be worn by persons who exhibit refractive astigmatism of 1.50 diopters or less where the astigmatism does not interfere with visual acuity.
- Product code
- LPL Lenses, Soft Contact, Daily Wear
- Reason for recall
- Contact lenses lack sterility assurance.
- Root cause tag
- manufacturing process
- FDA root cause
- Process design
- Action
- Consignees were initially called and told over the phone not to further distribute the contact lenses. For two consignees whose patients could not be reached by phone, a letter was sent. The consignee letter states the specific product and lot should not be further distributed due to the lack of sterility assurance. A business reply card was provided with the letter and contacts should be returned to the manufacturer using a label provided by the firm.
- Quantity in commerce
- 3
- Distribution
- Worldwide Distribution - US Nationwide in the states:of CA, FL, GA, ID, IL, IN, KS, KY, MD, MI, MO, MS, NC, NJ, NM, NV, NY, OH, OR, PA, TX, VA, WI, WY and the country of Canada.
- Product codes and lots
- AZ139610 AZ139620
Enforcement reports
One row per recalled product line| Recall number | Class | Status | Voluntary or mandated | Report date | Classified |
|---|---|---|---|---|---|
| Z-0981-2018 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0982-2018 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0983-2018 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0984-2018 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0985-2018 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0986-2018 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0987-2018 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0988-2018 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0989-2018 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0990-2018 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0991-2018 | Class II | Terminated | Voluntary: Firm initiated |
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