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

Model Number	SN60WF
Medical Device Problem Code	Scratched Material (3020)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	07/06/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Investigation including root cause analysis is in progress.A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when additional reportable information becomes available.The manufacturer internal reference number is: (b)(4).
Event or Problem Description
A non-healthcare professional reported that following the cataract surgery with intraocular lens implant procedure, lens found to have long linear scratch on the posterior face of the optic, right through the visual axis immediately after injection.Scratches are oriented 6-12 o¿clock.Upon injection, the scratch was at 3-9 o¿clock, but when positioned the lens into the bag, surgeon rotated it about 90 degrees clockwise to arrive at the 6-12 orientation.Additional information has been requested.
Additional Manufacturer Narrative
The lens was returned in the lens case.Viscoelastic was observed on the lens.The lens has a long narrow scratch on the posterior surface of the lens.The scratch extends from the center toward one optic/haptic junction area.This type of narrow scratch has been associated with instruments used to grasp the lens (metal forceps).Qualified associated products were indicated.The root cause for the observed lens damage could not be determined.No problem was found with the associated cartridge.There are no other complaints in this lot.The manufacturer internal reference number is: (b)(4).
Event or Problem Description
Additional information received and stated that the incident identified during surgery.Immediately upon insertion of the iol.There was no patient harm.

• 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: 15154794
• Report Number: 1119421-2022-01696
• Device Sequence Number: 17442328
• Product Code: HQL
• UDI-Device Identifier: 00380655093306
• UDI-Public: 00380655093306
• Combination Product (Y/N): N
• Initial Reporter State: HI
• Initial Reporter Country: US
• PMA/510(K) Number: P930014
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/13/2022

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 09/30/2024
• Device Model Number: SN60WF
• Device Catalogue Number: SN60WF.255
• Device Lot Number: 12752630
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/27/2022
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/06/2022
• Supplement Date Received by Manufacturer: 08/18/2022
• Initial Report FDA Received Date: 08/03/2022
• Supplement Report FDA Received Date: 09/13/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/15/2019
• 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 CARTRIDGE D; MONARCH INJECTOR; VISCOAT
• Outcome Attributed to Adverse Event: Other
• Patient Age: 80 YR
• Patient Sex: Female