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

Model Number	SN60WF
Medical Device Problem Code	Failure to Unfold or Unwrap (1669)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/01/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The lens was returned positioned incorrectly posterior side up in the lens case.Solution was dried on the lens.The lens was cleaned with lphse for further evaluation.The optic had a crack near the center of the lens.A fold inspection was conducted using folding tweezers.The lens folded and unfolded with no abnormalities observed.Complaint history and product history records were reviewed and the documentation indicated the product met release criteria.Qualified associated product were indicated.The associated handpiece was not provided.It is unknown if a qualified product was used.The product investigation could not identify a root cause for the reported complaint of "lens did not unfold properly".A fold inspection was conducted using folding tweezers.The lens folded and unfolded with no abnormalities observed.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 manager reported that during an intraocular lens (iol) implant procedure, the lens did not unfold properly when attempted to insert into a patient's eye.The procedure was completed the same day with another lens, same type, and diopter.

• 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: 12406840
• Report Number: 1119421-2021-01672
• Device Sequence Number: 14548500
• Product Code: HQL
• UDI-Device Identifier: 00380655093160
• UDI-Public: 00380655093160
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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): 09/01/2021

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: 01/18/2026
• Device Model Number: SN60WF
• Device Catalogue Number: SN60WF.185
• Device Lot Number: 15132476
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/12/2021
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/09/2021
• Initial Report FDA Received Date: 09/01/2021
• 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: DUOVISC OPHTHALMIC VISCOSURGICAL DEVICE; MONARCH III IOL DELIVERY SYSTEM, CARTRIDGE D
• Patient Age: 61 YR