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

Model Number	MA60AC
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Eye Injury (1845)
Date of Event	09/22/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The lens was returned positioned incorrectly posterior side up in the lens case.Blood and solution was dried on the lens.One haptic was bent in the distal area.The other haptic is pulled from the haptic insertion area (not returned).All product and batch history records are reviewed by quality prior to product release.Due to the surgeons technique, associated cartridge and handpiece were not used.The file indicated the use of two viscoelastics.The reported haptic damage was observed.Information was provided in the file that in the surgeons opinion the event was caused due to traction/tension of pulling on the two haptics which was due to type of surgical technique.The manufacturer internal reference number is: (b)(4).
Event or Problem Description
A physician reported that during implantation of an intraocular lens (iol) the haptic was broke with no patient contact.Additional information was received stating haptic was broke with patient contact.The lens was removed by wound enlargement.The wound was closed with sutures.The patient was not hospitalized for the event and there was no patient harm.In surgeons opinion the event was caused due to traction/tension of pulling on the two haptics which was due to type of surgical technique.

• Brand Name: ACRYSOF MULTIPIECE IOL
• Common Device Name: INTRAOCULAR LENS
• Manufacturer (Section D): ALCON RESEARCH, LLC - HUNTINGTON; 6065 kyle lane; huntington WV 25702
• MDR Report Key: 12743506
• Report Number: 1119421-2021-02048
• Device Sequence Number: 17265582
• Product Code: HQL
• UDI-Device Identifier: 00380652552387
• UDI-Public: 00380652552387
• Combination Product (Y/N): N
• Initial Reporter State: IN
• 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): 11/03/2021

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 06/30/2022
• Device Model Number: MA60AC
• Device Catalogue Number: MA60AC.130
• Device Lot Number: 12550936
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/19/2021
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/12/2021
• Initial Report FDA Received Date: 11/03/2021
• 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: BETADINE; DUOVISC; MICRO GRASPERS; MICROFORCEPS; PROVISC
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 62 YR