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

Model Number	ACU0T0
Medical Device Problem Codes	Device Damaged by Another Device (2915); Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/29/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Complaint history and product history records were reviewed and the documentation indicated the product met release criteria.The root cause has not been identified.There were no other complaints reported in the lot number.Additional information was requested.The manufacturer internal reference number is: (b)(4).
Event or Problem Description
A facility representative reported that during implantation of an intraocular lens (iol) the trailing haptic got caught on to the plunger and the lens was ripped.Additional information was requested.
Event or Problem Description
Additional information was received reporting that the lens was inserted/removed same day.
Additional Manufacturer Narrative
Only the opened product carton with some of the inner packaging components was returned.A qualified viscoelastic was indicated.The root cause cannot be determined for the event.Only the opened carton and packaging components were returned.Information was provided that a facility representative indicated that in the surgeon's opinion, the product did not cause or contribute to the event.No further information has been provided.The manufacturer internal reference number is: (b)(4).

• Brand Name: ACRYSOF IQ ASPHERIC UV ABSORBING IOLWITH ULTRASERT DELIVERY SYSTEM
• Common Device Name: LENS, GUIDE, INTRAOCULAR
• Manufacturer (Section D): ALCON RESEARCH, LLC - HUNTINGTON; 6065 kyle lane; huntington WV 25702
• MDR Report Key: 11878082
• Report Number: 1119421-2021-01100
• Device Sequence Number: 1073199
• Product Code: KYB
• UDI-Device Identifier: 00380652395205
• UDI-Public: 00380652395205
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: P930014
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/09/2021

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: 08/19/2023
• Device Model Number: ACU0T0
• Device Lot Number: 15091095
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/16/2021
• Initial Date Received by Manufacturer: 05/04/2021
• Supplement Date Received by Manufacturer: 07/16/2021
• Initial Report FDA Received Date: 05/25/2021
• Supplement Report FDA Received Date: 08/09/2021
• 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
• Patient Age: 78 YR