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

Model Number AU00T0

Device Problem Migration or Expulsion of Device (1395)

Patient Problem Insufficient Information (4580)

Event Date 10/08/2020

Event Type  Injury  

Manufacturer Narrative

Evaluation summary: the lens was returned submerged in clear solution inside a specimen cup.The lens was removed from the solution and allowed to air dry prior to evaluation.No damage was observed to the lens.A dimensional inspection (plan view) was conducted with the lens.The lens was within the specification per the approved template.All product and batch history records are quality reviewed prior to product release.Viscoelastic was not provided.It is unknown if the qualified product was used.The root cause cannot be determined for the reported issue.The manufacturer internal reference number is: 2020-57610.

Event Description

A facility representative reported that following a cataract surgery with an intraocular lens (iol) implantation, "the lens subluxated nasally, found it at the postop exam same day".The product is available in a specimen cup for return.Additional information has been requested.

Event Description

Corrected information was provided indicating that the iol was replaced with a different lens model.

Manufacturer Narrative

The manufacturer internal reference number is: (b)(4).

• Brand Name: ACRYSOF IQ SINGLEPIECE IOL WITH ULTRASERT DELIVERY SYSTEM
• Type of Device: LENS, GUIDE, INTRAOCULAR
• Manufacturer (Section D): ALCON RESEARCH, LLC - HUNTINGTON; 6065 kyle lane; huntington WV 25702
• MDR Report Key: 10731608
• MDR Text Key: 212961434
• Report Number: 1119421-2020-01543
• Device Sequence Number: 1
• Product Code: KYB
• Combination Product (y/n): N
• PMA/PMN Number: P930014
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Type of Report: Initial,Followup
• Report Date: 11/16/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/23/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2022
• Device Model Number: AU00T0
• Device Lot Number: 12759080
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/21/2020
• Date Manufacturer Received: 10/27/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: UNSPECIFIED DISCOVISC OVD, 000545, UNK, BEL.
• Patient Outcome(s): Required Intervention