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

Model Number	SA60WF
Medical Device Problem Codes	Device Damaged by Another Device (2915); Failure to Eject (4010)
Health Effect - Clinical Code	Eye Injury (1845)
Date of Event	06/16/2021
Type of Reportable Event	Serious Injury
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.There have been no other complaints reported in the lot number.The manufacturer internal reference number is: (b)(4).
Event or Problem Description
A nurse reported that during an intraocular lens (iol) implant procedure, the iol was caught in the cartridge and the haptic was squeezed off.The incision was enlarged and the procedure was completed with a back-up lens.No further information is available.
Additional Manufacturer Narrative
Half of the iol returned (half optic and one haptic) in a lens case.Solution is dried on both surfaces of the optic and one haptic.The haptic is bent/deformed.The optic is cracked/fractured and scratched/marked-rejectable.Unable to conduct dimensional testing due to condition of returned sample.No cartridge was returned.The product investigation could not identify the root cause for the reported complaint "iol was caught in the cartridge and squeezed" as only half of the iol was returned for evaluation.Due to this, we are unable to complete a thorough investigation to determine a root cause.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
• Manufacturer (Section G): ALCON LABORATORIES IRELAND LTD.; cork business&technology park; model farm road; cork 00000 ; EI 00000
• Manufacturer Contact: jonathan schlech ; 6201 south freeway; mail stop ab2-6; fort worth, TX 76134 ; 8007579780
• MDR Report Key: 12501971
• Report Number: 9612169-2021-00196
• Device Sequence Number: 16957786
• Product Code: HQL
• UDI-Device Identifier: 00380652332767
• UDI-Public: 00380652332767
• Combination Product (Y/N): N
• Initial Reporter Country: DA
• 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: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 12/24/2021

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 05/31/2025
• Device Model Number: SA60WF
• Device Catalogue Number: SA60WF.250
• Device Lot Number: 21275800
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/04/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/02/2021
• Supplement Date Received by Manufacturer: 12/02/2021
• Initial Report FDA Received Date: 09/20/2021
• Supplement Report FDA Received Date: 12/24/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/16/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: UNSPECIFIED CARTRIDGE
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown