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

Model Number ACU0T0

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Inflammation (1932); Iritis (1940); Eye Pain (4467)

Event Date 01/24/2021

Event Type  Injury  

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 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.

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
• Type of Device: INTRAOCULAR LENS
• Manufacturer (Section D): ALCON RESEARCH, LLC - HUNTINGTON; 6065 kyle lane; huntington WV 25702
• MDR Report Key: 11967738
• MDR Text Key: 255161019
• Report Number: 1119421-2021-01178
• Device Sequence Number: 1
• Product Code: HQL
• UDI-Device Identifier: 00380652395205
• UDI-Public: 00380652395205
• Combination Product (y/n): N
• PMA/PMN Number: P930014
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 07/19/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/09/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: 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
• Date Manufacturer Received: 06/28/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: PROVISC OVD; PROVISC OVD
• Patient Outcome(s): Required Intervention
• Patient Age: 73 YR