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 Code	Device Damaged by Another Device (2915)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/15/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Only the lens was returned in a small pouch.The device was not returned.Viscoelastic was observed on the lens.The lens optic was broken and cut into pieces.Only two large portions returned.One portion contained a full, intact haptic.This optic portion had a gouge mark near the optic center.This was most likely interpreted as the complaint.This optic portion also has a small nick/chipped area on the edge.A second broken optic portion had splintering cracked areas.Product history records were reviewed and documentation indicated the product met release criteria.The root cause cannot be determined for the reported event.Only broken portions of the lens was returned.A gouged area was observed near the optic center.This was most likely interpreted as the complaint.It is not possible to determine if the lens was in a proper position for advancement during delivery.Viscoelastic was not provided.It is unknown if the qualified product was used.Material properties of non-qualified ovds may contribute to underfill, overfill, misfolding of the haptics, or other inconsistent folding outcomes.There are no other complaints in the lot.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 iol was noted to be scratched.Although there was patient contact,the procedure was completed with another lens with no reported patient harm.Additional information has been requested.

• 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: 11651704
• Report Number: 1119421-2021-00808
• Device Sequence Number: 3496358
• Product Code: KYB
• UDI-Device Identifier: 00380652395151
• UDI-Public: 00380652395151
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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
• Report Date (Section B): 04/12/2021

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: 09/30/2021
• Device Model Number: ACU0T0
• Device Lot Number: 12663065
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/05/2021
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/22/2021
• Initial Report FDA Received Date: 04/12/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1