MAUDE Adverse Event Report: ALCON RESEARCH, LLC - HUNTINGTON ACRYSOF ASPHERIC UV ABSORBING SINGLEPIECE IOL; INTRAOCULAR LENS

Model Number	SA60WF
Medical Device Problem Code	Device Damaged by Another Device (2915)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/09/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The product was not returned for analysis.Product history and batch records were reviewed and documentation indicated the product met release criteria.The product investigation could not identify a root cause.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 an intraocular lens (iol) implant procedure the lens was damaged in the cartridge.The lens was cut out of eye and replaced with a new one.Additional information has been requested.
Event or Problem Description
Additional information was provided that there was no patient harm.
Additional Manufacturer Narrative
The manufacturer internal reference number is: (b)(4).
Additional Manufacturer Narrative
Product evaluation: the lens was returned advanced to the nozzle entry area of a qualified cartridge.Viscoelastic is observed in the cartridge.The lens and haptic position are acceptable for advancement.No lens damage is observed.The cartridge has evidence of placement into a handpiece.The returned sample does not match the reported complaint.Complaint history and product history records were reviewed and documentation indicated the product met release criteria.Qualified associated products were indicated.The lens and haptics are properly folded for advancement.No lens or cartridge damage was observed.It is unclear if the wrong sample was returned or if the wrong complaint information was provided.The reporter has not responded to follow up requests.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 RESEARCH, LLC - HUNTINGTON; 6065 kyle lane; huntington WV 25702
• MDR Report Key: 11649167
• Report Number: 1119421-2021-00799
• Device Sequence Number: 3496353
• Product Code: HQL
• UDI-Device Identifier: 00380652332651
• UDI-Public: 00380652332651
• Combination Product (Y/N): N
• Initial Reporter State: WA
• 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
• Remedial Action: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/03/2021

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: 10/12/2025
• Device Model Number: SA60WF
• Device Catalogue Number: SA60WF.195
• Device Lot Number: 15107587
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/04/2021
• Initial Date Received by Manufacturer: 03/23/2021
• Supplement Date Received by Manufacturer: 04/09/2021; 06/02/2021
• Initial Report FDA Received Date: 04/12/2021
• Supplement Report FDA Received Date: 04/29/2021; 06/03/2021
• 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; MONARCH III IOL DELIVERY SYSTEM, INJECTOR