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

Model Number	SA60WF
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A sample device was not returned for analysis.Product history records were reviewed and documentation indicated the product met release criteria.Root cause has not been identified.There have been no other complaints reported in the lot number.Additional information has been requested.The manufacturer internal reference number is: (b)(4).
Event or Problem Description
A certified surgical technician (cst) reported that following an intraocular lens (iol) implant procedure, the iol was dislocated in the eye.The iol was exchanged in a secondary procedure 15 days following the initial procedure.Additional information was requested.
Additional Manufacturer Narrative
The lens was returned adhered with viscoelastic to the outside of the lens case base.The lens had been cut into two pieces.The cut was across the optic center.Both haptics were intact.Lens dimensions could not be evaluated due to the returned damaged condition of the lens.The root cause for the reported dislocation could not be determined.The lens had been cut into two pieces, which is consistent with a lens removal.No other damage was observed.Information was provided that the company lens, 13.5 diopter lens was replaced with a company lens 13.5 (add power +2.2/+3.2) diopter lens.Follow up attempts were made.No further information has been provided.The manufacturer internal reference number is: (b)(4).

• 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: 12487398
• Report Number: 1119421-2021-01773
• Device Sequence Number: 3349836
• Product Code: HQL
• UDI-Device Identifier: 00380652332538
• UDI-Public: 00380652332538
• Combination Product (Y/N): N
• Initial Reporter State: SD
• Initial Reporter Country: US
• PMA/510(K) Number: P930014
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/04/2022

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 11/29/2025
• Device Model Number: SA60WF
• Device Catalogue Number: SA60WF.135
• Device Lot Number: 15118824
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/09/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/27/2021
• Supplement Date Received by Manufacturer: 12/14/2021
• Initial Report FDA Received Date: 09/17/2021
• Supplement Report FDA Received Date: 01/04/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/30/2020
• 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: ACRYSOF IQ PANOPTIX UV ABSORBING TRIFOCAL IOL; ACRYSOF IQ PANOPTIX UV ABSORBING TRIFOCAL IOL
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown