MAUDE Adverse Event Report: ALCON LABORATORIES IRELAND LTD. ACRYSOF SINGLEPIECE IOL; INTRAOCULAR LENS

Model Number	SA60AT
Medical Device Problem Code	Defective Device (2588)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/01/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The product was returned for analysis.Investigation including root cause analysis is in progress.A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when additional reportable information becomes available.Results from the product history record review indicated the product met release criteria.There have been no other complaints reported in the lot number.Additional information was requested.The manufacturer internal reference number is: (b)(4).
Event or Problem Description
A customer reported about an unsterile/defective lens.Additional information was requested.
Additional Manufacturer Narrative
Damage was observed to the iol.Iol returned pressed down on one(1) post of the lens case base resulting in gross haptic damage.Solution is dried on both surfaces of the optic and haptics.One haptic/optic junction is cracked/fractured-rejectable and is partially adhered due to being pressed on the lens case post.The optic is scratched/marked-rejectable.We are unable to determine the root cause for the reported complaint.The returned iol shows evidence of possible handling by the customer due to the presence of solution dried on the iol.In addition to this, all iols are 100% cosmetically inspected as per approved manufacturing procedures and the observed damage would not meet our current release criteria.Based on these investigation findings, we are unable to verify if the iol contributed to the event.All product and batch history records are quality reviewed prior to product release.The manufacturer internal reference number is: (b)(4).

• Brand Name: ACRYSOF SINGLEPIECE IOL
• Common Device Name: INTRAOCULAR LENS
• Manufacturer (Section D): ALCON LABORATORIES IRELAND LTD.; cork business&technology park; model farm road; cork 00000 ; EI 00000
• MDR Report Key: 11947156
• Report Number: 9612169-2021-00131
• Device Sequence Number: 1061248
• Product Code: HQL
• UDI-Device Identifier: 00380652556002
• UDI-Public: 00380652556002
• Combination Product (Y/N): N
• Initial Reporter Country: BE
• PMA/510(K) Number: P930014
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup
• Report Date (Section B): 08/05/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 05/31/2024
• Device Model Number: SA60AT
• Device Catalogue Number: SA60AT.300
• Device Lot Number: 21246865
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/02/2021
• Initial Date Received by Manufacturer: 05/14/2021
• Supplement Date Received by Manufacturer: 07/15/2021
• Initial Report FDA Received Date: 06/07/2021
• Supplement Report FDA Received Date: 08/05/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1