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U.S. Department of Health and Human Services

Class 1 Device Recall BAUSCHLOMB

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 Class 1 Device Recall BAUSCHLOMBsee related information
Date Initiated by FirmJune 12, 2024
Date PostedJuly 11, 2024
Recall Status1 Open3, Classified
Recall NumberZ-2254-2024
Recall Event ID 94793
Product Classification Kit, surgical instrument, disposable - Product Code KDD
ProductBAUSCH+LOMB, I-PACK Injection Kit with Wire Speculum, REF 18069W, for the administration of intravitreal injection (eye)
Code Information UDI/DI 20841305107612, Lot Number P62764970R
Recalling Firm/
Manufacturer		 Synergetics Inc
3845 Corporate Centre Dr
O Fallon MO 63368-8678
Manufacturer Reason
for Recall		Sterilization certificates could not be validated by the supplier
FDA Determined
Cause 2		Under Investigation by firm
ActionBausch + Lomb issued an URGENT MEDICAL DEVICE VOLUNTARY RECALL notice to its consignees on 05/12/2024 via FedEx. The notice explained the issue, potential hazard, and requested the following: Required actions: 1. Immediately review your inventory and isolate the affected products to prevent unintended use. Please complete and submit the attached Recall Acknowledgement Form that has instructions regarding what to do with product on-hand. You will receive a credit for any returned or destroyed kits. 2. If you have further distributed or transferred the affected product, identify and notify those to whom you have distributed the product by forwarding this letter with the recall acknowledgement form. For questions or need any other support with our products, reach out to your Bausch + Lomb sales representative or our customer service team at (800-338-2020).
Quantity in Commerce35 units
DistributionUS Nationwide
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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