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

Model Number	SN60WF
Medical Device Problem Codes	Failure to Fold (1255); Failure to Advance (2524)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	09/06/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The lens was returned positioned incorrectly in the lens case.Solution was dried on the lens.One haptic was bent in the gusset area against a post of the lens case.The lens was cleaned with klrp (klotho-related protein klrp).The haptic relaxed into original position after the removal of the dried viscoelastic.A fold test was conducted using folding tweezers.The lens folded and unfolded with no abnormalities observed.The associated cartridge was not returned.Product history records were reviewed and the documentation indicated the product met release criteria.The root cause cannot be determined for the reported complaint.The lens was not returned in the reported condition of "failure to deploy".The lens was not returned stuck in a cartridge.It is not possible to confirm the position of the lens while inside the associated non returned cartridge.There have been no other complaints reported in the lot number.The manufacturer internal reference number is: (b)(4).
Event or Problem Description
A non health care professional reported that during an intraocular lens (iol) implant procedure it was found that failure to deploy lens was folded.Additional information has been requested.

• 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
• Manufacturer (Section G): ALCON RESEARCH, LLC - HUNTINGTON; 6065 kyle lane; huntington WV 25702
• Manufacturer Contact: jonathan schlech ; 6201 south freeway; mail stop ab2-6; fort worth, TX 76134 ; 8007579780
• MDR Report Key: 15914386
• Report Number: 1119421-2022-02560
• Device Sequence Number: 4397784
• Product Code: HQL
• UDI-Device Identifier: 00380655093221
• UDI-Public: 00380655093221
• Combination Product (Y/N): N
• Initial Reporter State: WI
• 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): 12/05/2022

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 Model Number: SN60WF
• Device Catalogue Number: SN60WF.215
• Device Lot Number: 15390799
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/29/2022
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/09/2022
• Initial Report FDA Received Date: 12/05/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/13/2022
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: MONARCH III CARTRIDGE D; MONARCH INJECTOR; VISCOAT
• Patient Sex: Unknown