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

Model Number	SN60AT
Medical Device Problem Code	Inaccurate Delivery (2339)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/05/2021
Type of Reportable Event	Malfunction
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 facility representative reported that during an intraocular lens (iol) implant procedure the lens would not insert and would not set and had to use another to complete procedure.No patient harm documented.Additional information was requested and received.
Additional Manufacturer Narrative
The lens was returned for evaluation.Solution is dried on the lens.One haptic is bent in the gusset area and folded over and adhered to the optic by solution.The lens was cleaned with lphse.A fold inspection was conducted using folding tweezers.The lens folded and unfolded with no abnormalities observed.A dimensional inspection was performed.The lens dimensions are acceptable using an approved (plan view) template.Product history records were reviewed and documentation indicated the product met release criteria.Qualified associated products were indicated.There have been one other complaints reported in the lot number.The reported issue could not be verified.No problems were found with the returned lens.The manufacturer internal reference number is: (b)(4).

• Brand Name: ACRYSOF SINGLEPIECE IOL
• Common Device Name: INTRAOCULAR LENS
• Manufacturer (Section D): ALCON RESEARCH, LLC - HUNTINGTON; 6065 kyle lane; huntington WV 25702
• MDR Report Key: 11997586
• Report Number: 1119421-2021-01211
• Device Sequence Number: 11037690
• Product Code: HQL
• UDI-Device Identifier: 00380650130518
• UDI-Public: 00380650130518
• Combination Product (Y/N): N
• Initial Reporter State: TN
• 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,Followup
• Report Date (Section B): 07/28/2021

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: 04/30/2025
• Device Model Number: SN60AT
• Device Catalogue Number: SN60AT.310
• Device Lot Number: 15065319
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/01/2021
• Initial Date Received by Manufacturer: 05/25/2021
• Supplement Date Received by Manufacturer: 07/12/2021
• Initial Report FDA Received Date: 06/15/2021
• Supplement Report FDA Received Date: 07/28/2021
• 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: DUOVISC; MONARCH II CARTRIDGE B; MONARCH III INJECTOR; DUOVISC; MONARCH II CARTRIDGE B; MONARCH III INJECTOR
• Patient Age: 63 WK