MAUDE Adverse Event Report: ALCON RESEARCH, LLC - HUNTINGTON ACRYSOF IQ SINGLEPIECE IOL WITH ULTRASERT DELIVERY SYSTEM; LENS, GUIDE, INTRAOCULAR

Model Number	AU00T0
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	Visual Disturbances (2140)
Date of Event	02/19/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Evaluation summary: 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 has been requested.The manufacturer internal reference number is: (b)(4).
Event or Problem Description
A customer reported following the implant of an intraocular lens (iol) the patient experienced a smudge in her vision.The surgeon reports a bubble like area in the center of the lens as well as the top part of the lens.Additional information was requested.
Additional Manufacturer Narrative
The previous report submitted for this event contained an error in h.1.- ¿summary report¿ was inadvertently selected.After a recent systems update, a system error caused the inadvertent additional selection of ¿summary report¿ in h.1.On a select number of reports.The error, which was limited only to the h.1.Field, was promptly identified and quickly rectified.Correction smdrs are being filed for the impacted reports.This smdr is correcting that error for this event.The manufacturer internal reference number is: (b)(4).
Additional Manufacturer Narrative
Product evaluation: the product was not returned for evaluation.Photos were provided of the lens in the eye.Medical safety review of photos.Six total photos are provided in this case, five of which are of the iol in question.Four of the five photos show direct illumination of the central portion of the iol through a well dilated pupil.In the very center of the iol there appears to be a circular anomaly of unknown provenance that stands out because it is slightly darker in appearance than the surrounding area.A second circular anomaly is also visible superiorly along the capsulorhexis margin.It is unknown whether this observation is something on the surface or within the iol.The fifth photo of the eye shows retroillumination also through a well dilated pupil.There does not appear to be any observable posterior capsular opacification in this photo.Root cause: a root cause could not be determined for the reported event.The product was not returned for evaluation.Photos were provided.A determination could not be made from the provided photos.Six total photos are provided in this case, five of which are of the iol in question.Four of the five photos show direct illumination of the central portion of the iol through a well dilated pupil.In the very center of the iol there appears to be a circular anomaly of unknown provenance that stands out because it is slightly darker in appearance than the surrounding area.A second circular anomaly is also visible superiorly along the capsulorhexis margin.It is unknown whether this observation is something on the surface or within the iol.The fifth photo of the eye shows retroillumination also through a well dilated pupil.There does not appear to be any observable posterior capsular opacification in this photo.Patient is to be re-evaluated at a future date.File will be reopened if further information is received.The manufacturer internal reference number is: (b)(4).

• Brand Name: ACRYSOF IQ SINGLEPIECE IOL WITH 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: 11404484
• Report Number: 1119421-2021-00462
• Device Sequence Number: 14246003
• Product Code: KYB
• UDI-Device Identifier: 00380652358033
• UDI-Public: 00380652358033
• Combination Product (Y/N): N
• Initial Reporter State: KY
• Initial Reporter Country: US
• PMA/510(K) Number: P930014
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/11/2021

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 04/30/2019
• Device Model Number: AU00T0
• Device Lot Number: 12462364
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/19/2021
• Supplement Date Received by Manufacturer: 03/03/2021; 04/28/2021
• Initial Report FDA Received Date: 03/03/2021
• Supplement Report FDA Received Date: 03/17/2021; 05/11/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 74 YR