MAUDE Adverse Event Report: ALCON RESEARCH, LLC - HUNTINGTON ACRYSOF IQ ASPHERIC UV ABSORBING IOLWITH ULTRASERT DELIVERY SYSTEM; INTRAOCULAR LENS

Model Number	ACU0T0
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Inflammation (1932); Iritis (1940); Eye Pain (4467)
Date of Event	01/24/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A sample device was not returned for analysis.Complaint history and 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 was requested.A questionnaire was received.The manufacturer internal reference number is: (b)(4).
Event or Problem Description
A facility representative reported that following an intraocular lens (iol) implant procedure, the patient had chronic inflammation with associated ocular pain.The iol was explanted 6 months following the initial procedure.The patient harm ocular pain/iritis was reported.The physician's prognosis was guarded.The patient left aphakic and will require additional surgery for secondary implant at later date.
Additional Manufacturer Narrative
The lens was returned in a specimen cup in solution.The lens has been cut into two pieces, typical of a removal.The optic has scratches.No foreign material or imbeds observed in the lens material.A qualified viscoelastic was indicated.The root cause for the reported events could not be determined.No abnormalities or foreign material were observed.File will be reopened, if new information is received.The manufacturer internal reference number is: (b)(4).

• Brand Name: ACRYSOF IQ ASPHERIC UV ABSORBING IOLWITH ULTRASERT DELIVERY SYSTEM
• Common Device Name: INTRAOCULAR LENS
• Manufacturer (Section D): ALCON RESEARCH, LLC - HUNTINGTON; 6065 kyle lane; huntington WV 25702
• MDR Report Key: 11967738
• Report Number: 1119421-2021-01178
• Device Sequence Number: 4219210
• Product Code: HQL
• UDI-Device Identifier: 00380652395205
• UDI-Public: 00380652395205
• Combination Product (Y/N): N
• Initial Reporter State: LA
• Initial Reporter Country: US
• PMA/510(K) Number: P930014
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/19/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 08/17/2023
• Device Model Number: ACU0T0
• Device Lot Number: 15091094
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 06/09/2021
• Initial Date Received by Manufacturer: 05/20/2021
• Supplement Date Received by Manufacturer: 06/28/2021
• Initial Report FDA Received Date: 06/09/2021
• Supplement Report FDA Received Date: 07/19/2021
• 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: PROVISC OVD; PROVISC OVD
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 73 YR