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

Model Number	SN60WF
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Capsular Bag Tear (2639)
Date of Event	07/26/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A sample device was not returned for analysis.Complaint history and product history records were reviewed and documentation indicated the product met release criteria.Root cause has not been identified.There have been no other complaints reported in the lot number.The manufacturer internal reference number is: (b)(4).
Event or Problem Description
A materials management reported that during an intraocular lens (iol) implant procedure, a torn capsule was discovered.Additional information was provided indicating that there was patient contact and that the procedure was completed.The patient¿s issues have resolved.
Additional Manufacturer Narrative
The lens and the qualified company cartridge were returned, inside the opened lens carton, along with the disassembled lens case.Only one half of the optic was returned in the lens case.Solution was dried on the lens.The area of one haptic was observed, to the broken in the haptic/optic junction.The broken haptic was not returned.The second haptic area of the lens could not be evaluated, due to other half of the optic was not returned.The returned optic portion had no additional damage.The used qualified company cartridge has an insufficient amount of viscoelastic.The tip has stress marks.The cartridge has evidence of being placed into a handpiece.The cartridge was cleaned for further evaluation.Top coat dye stain test was conducted with acceptable results.Viscoelastic information was not provided.It is unknown, if a qualified viscoelastic was used.The root cause of the reported complaint, may be related to a failure to follow the instructions for use (ifu).An inadequate amount of viscoelastic was observed, in the cartridge.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: 12406624
• Report Number: 1119421-2021-01673
• Device Sequence Number: 14548499
• Product Code: HQL
• UDI-Device Identifier: 00380655095676
• UDI-Public: 00380655095676
• Combination Product (Y/N): N
• Initial Reporter State: TN
• 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): 10/06/2021

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: 03/07/2026
• Device Model Number: SN60WF
• Device Catalogue Number: SN60WF.130
• Device Lot Number: 15165116
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/07/2021
• Initial Date Received by Manufacturer: 08/09/2021
• Supplement Date Received by Manufacturer: 09/10/2021
• Initial Report FDA Received Date: 09/01/2021
• Supplement Report FDA Received Date: 10/06/2021
• 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 IOL DELIVERY SYSTEM, CARTRIDGE D; UNKNOWN CARTRIDGE; UNKNOWN VISCOELASTIC; MONARCH III IOL DELIVERY SYSTEM, CARTRIDGE D; UNKNOWN CARTRIDGE; UNKNOWN VISCOELASTIC
• Outcome Attributed to Adverse Event: Other
• Patient Age: 67 YR