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

Model Number	SA60WF
Medical Device Problem Code	Failure to Advance (2524)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/11/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The lens was returned in the lens case with one of the haptics folded typical of being loaded into a cartridge.Solution is dried on the lens.One haptic is bent in the gusset area and folded over and adhered to the optic by solution.The opposite haptic is broken in the gusset area and returned adhered to the optic by solution.Edge damage is observed in two spots on the optic with missing and loose material.A small scratch is observed on the optic.A crack is observed on the optic.Product history records were reviewed and the documentation indicated the product met release criteria.Qualified associated products were indicated.The cartridge was not returned for evaluation.A dimensional inspection could not be performed due to the extensive damage.The product investigation could not identify a root cause for the reported complaint of lens would not load.The lens was returned in the lens case.The cartridge was not returned for evaluation.There have been no other complaints reported in the lot number.The manufacturer internal reference number is: (b)(4).
Event or Problem Description
A health professional reported that during implantation of an intraocular lens (iol), the lens would not advance through the wound.Patient contact was noted.

• 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: 11986124
• Report Number: 1119421-2021-01203
• Device Sequence Number: 19673841
• Product Code: HQL
• UDI-Device Identifier: 00380652332705
• UDI-Public: 00380652332705
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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
• Report Date (Section B): 06/11/2021

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: 02/08/2026
• Device Model Number: SA60WF
• Device Catalogue Number: SA60WF.220
• Device Lot Number: 15145466
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/07/2021
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/18/2021
• Initial Report FDA Received Date: 06/11/2021
• 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; PROVISC OPHTHALMIC VISCOSURGICAL DEVICE
• Patient Age: 65 YR