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

Model Number	SA60WF
Medical Device Problem Code	Crack (1135)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/24/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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.The manufacturer internal reference number is: (b)(4).
Event or Problem Description
A customer reported an intraocular lens (iol) cracked in the middle possibly due to the cartridge.The lens was removed and replaced without incident.Additional information is requested.There are two related reports for this event.This report addresses the iol, and another manufacturer report will be filed for the cartridge.
Additional Manufacturer Narrative
Product evaluation: and empty lens case returned along with secondary labels and questioner.No iol returned.Root cause: no root cause identified as no iol was returned for evaluation.Based on these investigation findings and the lack of sample, we are unable to determine a root cause for the reported complaint.All product and batch history records are quality reviewed prior to product release.The manufacturer internal reference number is: (b)(4).

• Brand Name: ACRYSOF ASPHERIC UV ABSORBING 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: 11660250
• Report Number: 9612169-2021-00085
• Device Sequence Number: 17028686
• Product Code: HQL
• UDI-Device Identifier: 00380652332606
• UDI-Public: 00380652332606
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: P930014
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/09/2021

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: 05/31/2025
• Device Model Number: SA60WF
• Device Catalogue Number: SA60WF.170
• Device Lot Number: 21275809
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/12/2021
• Initial Date Received by Manufacturer: 03/30/2021
• Supplement Date Received by Manufacturer: 06/11/2021
• Initial Report FDA Received Date: 04/13/2021
• Supplement Report FDA Received Date: 07/09/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: DUOVISC; DUOVISC VISCOELASTIC SYSTEM; MONARCH III; MONARCH III IOL DELIVERY SYSTEM, CARTRIDGE D
• Patient Age: 70 YR