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

Model Number SND1T3

Device Problem Mechanical Problem (1384)

Patient Problem No Code Available (3191)

Event Date 10/06/2007

Event Type  Injury  

Manufacturer Narrative

Summary evaluation: complaint history and product history record could not be reviewed because the reporting facility did not provide a valid lot number or any identification traceable to the manufacturing documentation root cause has not been identified.There have been no other complaints reported in the lot number.Attempts have been made to obtain additional information.(b)(4).

Event Description

A surgeon reported that one week following intraocular lens (iol) implant procedure, the lens rotated 50 degrees.He repositioned the lens in a secondary procedure.He indicated the patient has a large capsulorrhexis.Additional information was requested.

Manufacturer Narrative

Evaluation summary: the iol product history records were reviewed and documentation indicates the product met release criteria.Cartridge and handpiece product history records could not be reviewed because facility did not provide a lot number or any identification traceable to the manufacturing documentation.Root cause has not been identified.(b)(4).

Event Description

Additional information was provided by a certified ophthalmic technician that the initial cataract extraction with iol implant procedure was performed ten years ago.A reposition of the iol was performed, but two weeks later the iol had rotated again.The iol was exchanged approximately two weeks later.The event has now resolved.

Manufacturer Narrative

(b)(4).

Event Description

Additional information was provided by the initial reporter that the patient experienced blurry vision.

• Brand Name: ACRYSOF RESTOR TORIC SINGLEPIECE IOL
• Type of Device: LENS, INTRAOCULAR, TORIC OPTICS
• Manufacturer (Section D): ALCON RESEARCH, LLC - HUNTINGTON; 6065 kyle lane; huntington WV 25702
• Manufacturer (Section G): ALCON RESEARCH, LLC - HUNTINGTON; 6065 kyle lane; huntington WV 25702
• Manufacturer Contact: nadia bailey ; 6201 south freeway; mail stop ab2-6; fort worth, TX 76134 ; 8176152230
• MDR Report Key: 7047817
• MDR Text Key: 92588035
• Report Number: 1119421-2017-01329
• 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: health professional
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 03/08/2019

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: 01/31/2022
• Device Model Number: SND1T3
• Device Catalogue Number: SND1T3U110
• Device Lot Number: 12521833
• Other Device ID Number: 00380652268851
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/24/2017
• Initial Date FDA Received: 11/21/2017
• Supplement Dates Manufacturer Received: 12/19/2017; 02/13/2019
• Supplement Dates FDA Received: 01/18/2018; 03/08/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/16/2017
• 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
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 54 YR