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

Model Number	SA60WF
Medical Device Problem Codes	Defective Device (2588); Failure to Eject (4010)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/07/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The lens case was returned fully disassembled.The lens was returned outside the lens case adhered by solution to the lens case base.Solution was dried on the lens.The lens was cleaned for further evaluation.The optic has a deep scrape mark on the anterior side between the optic edge and center of the lens.A dimensional inspection was conducted.The lens met specifications per the approved (plan view) template.No cartridge was returned for evaluation.All product and batch history records are quality reviewed prior to product release.Qualified associated products were indicated.The product investigation could not identify a root cause for the reported complaint.The lens was returned outside of the fully disassembled lens case adhered by solution to the lens case base and was not returned in a cartridge as described for evaluation.The qualified associated cartridge was not returned for evaluation.The returned lens was cleaned for further evaluation.The optic has a deep scrape mark on the anterior side.All lenses are 100% inspected for cosmetic attributes and the damage exhibited by the returned complaint sample would not have met company 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 lens dimensions are acceptable using an approved (plan view) template.The manufacturer internal reference number is: (b)(4).
Event or Problem Description
A nurse reported that during an intraocular lens (iol) implant procedure, the lens did not load properly.Additional information was provided stated that lens was stuck in the cartridge and possible injector issue, it was unsure if it was the lens, cartridge or the injector was being used there was no patient harm and the surgeon prognosis was good.The patient was not hospitalized.

• 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 ; 8175514979
• MDR Report Key: 12796628
• Report Number: 1119421-2021-02107
• Device Sequence Number: 14738240
• Product Code: HQL
• UDI-Device Identifier: 00380652332774
• UDI-Public: 00380652332774
• Combination Product (Y/N): N
• Initial Reporter State: AL
• 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
• Type of Report: Initial
• Report Date (Section B): 11/11/2021

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 07/27/2026
• Device Model Number: SA60WF
• Device Catalogue Number: SA60WF.255
• Device Lot Number: 15240433
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/03/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/21/2021
• Initial Report FDA Received Date: 11/11/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/29/2021
• 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 DELIVERY SYSTEM, CARTRIDGE D; MONARCH III IOL DELIVERY SYSTEM, INJECTOR; PROVISC OPHTHALMIC VISCOSURGICAL DEVICE
• Patient Age: 72 YR
• Patient Sex: Female