MAUDE Adverse Event Report: ALCON RESEARCH, LLC - HUNTINGTON ACRYSOF ASPHERIC UV ABSORBING SINGLEPIECE IOL; INTRAOCULAR LENS

Model Number	SA60WF
Medical Device Problem Code	Difficult to Advance (2920)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/15/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The lens was returned for evaluation.Solution is dried on the lens.One haptic is broke along with a portion of the optic where the haptic was attached (not returned).The opposite haptic is pressed against a post in the lens case in the gusset area causing the haptic to bent and twist pointing down into the lens case.The lens is pressed against and between three posts in the lens case.Two small cracks are observed on the optic near the broken portion.A dimensional inspection could not be conducted due to extensive damage.Product history records were reviewed and the documentation indicated the product met release criteria.The cartridge was not returned for evaluation.The file indicated the use of a qualified cartridge and an unspecified handpiece.The viscoelastic mentioned is only qualified with an approved cartridge and handpiece combination.The product investigation could not identify a root cause for the reported complaint of lens would not advance forward.It is unknown if qualified associated products were used.A dimensional inspection could not be conducted due to extensive damage.There are no other complaints in this lot.The manufacturer internal reference number is: (b)(4).
Event or Problem Description
A non-healthcare professional reported that during an intraocular lens (iol) implant procedure, lens stuck halfway in the eye and will not advance forward during insertion.Additional information was requested.

• Brand Name: ACRYSOF ASPHERIC UV ABSORBING 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: 13717999
• Report Number: 1119421-2022-00435
• Device Sequence Number: 6055331
• Product Code: HQL
• UDI-Device Identifier: 00380652332804
• UDI-Public: 00380652332804
• Combination Product (Y/N): N
• Initial Reporter State: NC
• 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): 03/10/2022

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: 08/10/2026
• Device Model Number: SA60WF
• Device Catalogue Number: SA60WF.270
• Device Lot Number: 15243151
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/28/2022
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/17/2022
• Initial Report FDA Received Date: 03/10/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/12/2021
• 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, CARTRIDGE C; MONARCH IOL, INJECTOR,; PROVISC
• Patient Age: 79 YR
• Patient Sex: Female