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

Model Number	MA60AC
Medical Device Problem Code	Failure to Advance (2524)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/11/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The lens was returned for evaluation.Solution is dried on the lens.The optic is pressed against a post in the lens case.Edge damage is observed where it is pressed against the post and a large piece of lens material is broken.The lens was cleaned for further evaluation.Light scratches are observed on the optic.A dimensional inspection was performed.The lens dimensions are acceptable (plan view) using an approved template.Product history records were reviewed and the documentation indicated the product met release criteria.An unspecified cartridge with a company handpiece and viscoelastic was indicated to be used.Without the cartridge model we can not verify if this was a qualified combination.The product investigation could not identify a root cause for the reported complaint of the lens stuck in the cartridge.The lens was not returned in the cartridge.The lens was returned in the lens case.No damage is observed to the haptics.A dimensional inspection was performed.The lens dimensions are acceptable (plan view) using an approved template.The cartridge was not returned for evaluation.The manufacturer internal reference number is: (b)(4).
Event or Problem Description
An operating room manager reported that during implantation of an intraocular lens (iol) the lens would not advance with patient contact.The procedure was completed on the same day with another device.Additional information was received stating the patient was not hospitalized for the event and there was no patient harm.

• Brand Name: ACRYSOF MULTIPIECE 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: 13450967
• Report Number: 1119421-2022-00183
• Device Sequence Number: 20367781
• Product Code: HQL
• UDI-Device Identifier: 00380652552271
• UDI-Public: 00380652552271
• Combination Product (Y/N): N
• Initial Reporter State: MD
• 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): 02/04/2022

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 Expiration Date: 09/15/2026
• Device Model Number: MA60AC
• Device Catalogue Number: MA60AC.075
• Device Lot Number: 15265133
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/19/2022
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/14/2022
• Initial Report FDA Received Date: 02/04/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/17/2021
• 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 IOL INJECTOR; PROVISC; UNSPECIFIED CARTRIDGE
• Patient Age: 47 YR
• Patient Sex: Male