MAUDE Adverse Event Report: ALCON RESEARCH, LLC - HUNTINGTON ACRYSOF IQ RESTOR TORIC SINGLEPIECE IOL; LENS, INTRAOCULAR, TORIC OPTICS

Model Number SV25T5

Device Problems Malposition of Device (2616); Unintended Movement (3026)

Patient Problems Failure of Implant (1924); Blurred Vision (2137); Visual Disturbances (2140)

Event Date 02/20/2019

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 has been requested.(b)(4).

Event Description

A surgical coordinator reported that following an intraocular lens (iol) implant procedure, the lens rotated causing blurry vision and diplopia due to the iol incorrectly positioned.The iol is expected to be exchanged.Additional information has been requested.

Manufacturer Narrative

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

Event Description

In a follow up, the surgical coordinator reported the iol was removed and replaced with another iol during a secondary procedure.The patient's issues have resolved following the iol exchange.

• Brand Name: ACRYSOF IQ RESTOR TORIC SINGLEPIECE IOL
• Type of Device: LENS, INTRAOCULAR, TORIC OPTICS
• Manufacturer (Section D): ALCON RESEARCH, LLC - HUNTINGTON; 6065 kyle lane; huntington WV 25702
• MDR Report Key: 8512436
• MDR Text Key: 142207428
• Report Number: 1119421-2019-00475
• Device Sequence Number: 1
• Product Code: MJP
• Combination Product (y/n): N
• PMA/PMN Number: P040020
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 05/10/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2022
• Device Model Number: SV25T5
• Device Catalogue Number: SV25T5U205
• Device Lot Number: 12573305
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/20/2019
• Initial Date FDA Received: 04/13/2019
• Supplement Dates Manufacturer Received: 04/15/2019
• Supplement Dates FDA Received: 05/10/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 69 YR