Recall record at a glance
| Official record | Z-1747-2013 |
|---|---|
| Category | Medical Device Recalls |
| Classification | Class II |
| FDA record status | Terminated |
| Recalling firm | Staar Surgical Co. |
| Report date | Jul 24, 2013 |
| Recall initiation date | Jun 10, 2013 |
| Quantity | 3,361 units total |
| Location | Monrovia, CA, United States |
Official product description
Afinity CQ2015A Intraocular Lens The visual correction of aphakia in persons 60 years of age or older in whom a cataractous lens has been removed by cataract extraction.
Why the product was recalled
STAAR Surgical Company is recalling a limited number of nanoFLEX CC4204A and Afinity CQ2015A intraocular lenses due to the potential presence of glass particles in the storage vial.
Distribution information
Nationwide distribution: USA including states of: AL,AZ, CA, CO, CT, FL, GA, HI, KY, IA, IL, IN, LA, MA, MI, MN, MO, MS, NC, NE, NH, NJ, NM, NV, NY, OH, PA, SC, TN, TX, UT, VA, WI, and WV.
How to read the classification
FDA Class II indicates a situation in which use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or where the probability of serious consequences is remote. The classification shown here comes from the FDA record.
Additional record details
Recall type: Voluntary: Firm initiated. Initial notification: Letter.
What to do next
If you believe you have the recalled product, use the recall number and firm information above to confirm the official notice and follow the instructions issued by the FDA, recalling firm, retailer or product manufacturer. For drugs and medical devices, decisions about treatment or medical care should be discussed with a qualified health professional.
About this record
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