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

Model Number SND1T3

Device Problems Degraded (1153); Unintended Movement (3026)

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

Event Type  Injury  

Manufacturer Narrative

Evaluation summary: the device was not returned for evaluation.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 Description

A customer reported following an intraocular lens (iol) implant procedure, the patient experienced blurred and double vision.The patient was not happy with the image quality of the multifocal.The surgeon reported the toric axis rotated and the lens decentered.Additional information was received reporting when the lens was removed, the surgeon noted there was nothing wrong with the removed lens.

Manufacturer Narrative

The customer indicated the use of an unspecified company cartridge.Cartridge product history records could not be reviewed because the reporting facility did not provide a lot number or any identification traceable to the manufacturing documentation.The customer indicated the use of a viscoelastic, which is not qualified for provided cartridge use.Information was provided that the multifocal lens 22.0 diopter lens was replaced with a monofocal lens, but details of the replacement lens were not given.The manufacturer internal reference number is: (b)(4).

• Brand Name: ACRYSOF RESTOR TORIC SINGLEPIECE IOL
• Type of Device: LENS, INTRAOCULAR, TORIC OPTICS
• Manufacturer (Section D): ALCON RESEARCH, LTD. - HUNTINGTON; 6065 kyle lane; huntington WV 25702
• Manufacturer (Section G): ALCON RESEARCH, LTD. - HUNTINGTON; 6065 kyle lane; huntington WV 25702
• Manufacturer Contact: cindy milam ; 6201 south freeway; mail stop ab2-6; fort worth, TX 76134 ; 8176152230
• MDR Report Key: 7922491
• MDR Text Key: 122193254
• Report Number: 1119421-2018-01415
• Device Sequence Number: 1
• Product Code: MJP
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P040020
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 11/29/2018

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: 01/31/2022
• Device Model Number: SND1T3
• Device Catalogue Number: SND1T3U220
• Device Lot Number: 12520681
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 09/12/2018
• Initial Date FDA Received: 10/01/2018
• Supplement Dates Manufacturer Received: 11/24/2018
• Supplement Dates FDA Received: 11/29/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/10/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: ATLONGB VISCOELASTIC; MONARCH III CARTRIDGE
• Patient Outcome(s): Required Intervention