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

Model Number	SN6AT5
Medical Device Problem Code	Defective Device (2588)
Health Effect - Clinical Codes	Eye Injury (1845); Visual Impairment (2138)
Date of Event	12/16/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Product evaluation: the lens was returned for evaluation.Solution is dried on the lens.One haptic is broken in the distal tip.One haptic is cracked in the gusset area.The lens has been cut in half, typical of insertion and removal.Marks are observed on the optical that are consistent with surgical forceps.Scratches are observed on the optic.All product and batch history records are quality reviewed prior to product release.There are no other complaints in this lot.Unspecified associated products were indicated.It is unknown if qualified products were used.Root cause: the reported haptic damage was observed.All lenses are 100% inspected for cosmetic attributes and the damage exhibited by the returned complaint sample would not have met alcon¿s release criteria.Based on our observation, and the review of manufacturing records, it can be reasonably concluded that the damage is not manufacturing related.Due to the presence of surgical solution and the condition of the returned sample, the damage is most likely related to customer handling.The manufacturer internal reference number is: (b)(4).
Event or Problem Description
A health care professional reported that a defective haptic was found during a cataract surgery with intraocular lens (iol) implantation.The lens was removed without enlargement of incision.The explantation of iol put additional stress on the main incision, likely resulting in induced astigmatism.Additional information has been requested.Medwatch reference number: mw5098602.

• Brand Name: ACRYSOF IQ TORIC SINGLEPIECE IOL
• Common Device Name: LENS, INTRAOCULAR, TORIC OPTICS
• Manufacturer (Section D): ALCON RESEARCH, LLC - HUNTINGTON; 6065 kyle lane; huntington WV 25702
• MDR Report Key: 11690804
• Report Number: 1119421-2021-00843
• Device Sequence Number: 3520636
• Product Code: MJP
• UDI-Device Identifier: 00380652251068
• UDI-Public: 00380652251068
• Combination Product (Y/N): N
• Initial Reporter State: OR
• Initial Reporter Country: US
• PMA/510(K) Number: P930014
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Nurse
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 04/19/2021

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: 02/25/2025
• Device Model Number: SN6AT5
• Device Catalogue Number: SN6AT5.235
• Device Lot Number: 15037555
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/05/2021
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/29/2021
• Initial Report FDA Received Date: 04/19/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 70 YR