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

Model Number SND1T3

Device Problems Material Discolored (1170); Defective Component (2292)

Patient Problem Visual Impairment (2138)

Event Date 03/15/2018

Event Type  malfunction  

Manufacturer Narrative

Evaluation summary: the product was not returned for analysis.Product history and batch records were reviewed and documentation indicated the product met release criteria.The product investigation could not identify a root cause.There have been no other complaints reported in the lot number.(b)(4).

Event Description

A doctor reported that six years following a cataract extraction with intraocular lens (iol) implant procedure, the lens is now totally white.The patient was seen three years ago, and the lens was in good condition.Since this year the patient stated that her vision began to diminish.Additional information was requested.

• 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: bryan blake ; 6201 south freeway; mail stop ab2-6; fort worth, TX 76134 ; 8176152230
• MDR Report Key: 7569304
• MDR Text Key: 110360140
• Report Number: 1119421-2018-00705
• Device Sequence Number: 1
• Product Code: MJP
• Combination Product (y/n): N
• Reporter Country Code: PM
• PMA/PMN Number: P040020
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 06/05/2018

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
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2015
• Device Model Number: SND1T3
• Device Catalogue Number: SND1T3.300
• Device Lot Number: 12001953
• Other Device ID Number: 00380652268172
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/09/2018
• Initial Date FDA Received: 06/05/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/17/2011
• 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
• Patient Outcome(s): Other