MAUDE Adverse Event Report: ALCON RESEARCH, LLC - HUNTINGTON ACRYSOF IQ NATURAL SINGLEPIECE IOL; INTRAOCULAR LENS

Model Number	SN60WF
Medical Device Problem Codes	Difficult to Advance (2920); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Eye Injury (1845)
Date of Event	05/03/2021
Type of Reportable Event	Serious Injury
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.The manufacturer internal reference number is: (b)(4).
Event or Problem Description
A facility representative reported that during the intraocular lens implantation procedure there was difficulty advancing lens into eye, surgeon widened incision.There was no patient harm.
Additional Manufacturer Narrative
Correction: on initial mdr the evaluation method code of 4113 was an error.It should have been 4114 on the original mdr ¿ (corrected information provided in h.10.) the lens was returned for evaluation.Solution and blood are dried on the lens.Both haptics are folded over and adhered to the optic by solution, typical of being folded and placed into a cartridge.The optic is pressed against two posts in the lens case.Qualified products were indicated.The cartridge was not returned for evaluation.Information was provided that the cause of the event was that the surgeon did not make the initial incision wide enough.Information also indicated the subsequent "failure" was related to the doctor.No specifics were provided.A malfunction was not indicated against the product.There are no other complaints in this lot.The manufacturer internal reference number is: (b)(4).

• Brand Name: ACRYSOF IQ NATURAL SINGLEPIECE IOL
• Common Device Name: INTRAOCULAR LENS
• Manufacturer (Section D): ALCON RESEARCH, LLC - HUNTINGTON; 6065 kyle lane; huntington WV 25702
• MDR Report Key: 11992930
• Report Number: 1119421-2021-01209
• Device Sequence Number: 922863
• Product Code: HQL
• UDI-Device Identifier: 00380655093177
• UDI-Public: 00380655093177
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: P930014
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/08/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 10/20/2025
• Device Model Number: SN60WF
• Device Catalogue Number: SN60WF.190
• Device Lot Number: 15109317
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/17/2021
• Initial Date Received by Manufacturer: 05/25/2021
• Supplement Date Received by Manufacturer: 06/18/2021
• Initial Report FDA Received Date: 06/14/2021
• Supplement Report FDA Received Date: 07/08/2021
• 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: MONARCH III CARTRIDGE D.; MONARCH III INJECTOR.; PROVISC.; MONARCH III CARTRIDGE D; MONARCH III INJECTOR; PROVISC
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 72 YR