FDAClass IINovember 9, 2022

Bausch + Lomb Cataract Pack recall

BAUSCH + LOMB CATARACT PACK, REF VAL001CPMEA. Convenience kit used in surgical procedures.

Why was Bausch + Lomb Cataract Pack recalled?

Medline received complaints on some of the breather pouches with in the sterile surgical kits show openings in the seal.

What should I do if I have this product?

The recall is ongoing. Follow the firm and FDA instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

GTIN (01) 10195327108168, Lot Number 22DBL466

Product
BAUSCH + LOMB CATARACT PACK, REF VAL001CPMEA. Convenience kit used in surgical procedures.
Recalling firm
MEDLINE INDUSTRIES, LP - Northfield
Quantity
708 kits
Distribution
US Nationwide distribution in the states of CA, MN, NC, NY, OK, PA, TN, TX.
Recall date
November 9, 2022
Classification
Class II
Status
Ongoing
Agency
FDA (device)
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