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

Model Number SND1T4

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problems Headache (1880); Blurred Vision (2137); Dizziness (2194)

Event Type  Injury  

Manufacturer Narrative

The device was received by a company representative and is in process to transit to the manufacturing site for investigation.Investigation including root cause analysis will be completed.A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when additional reportable information becomes available.Product history records were reviewed and documentation indicated the product met release criteria.There have been no other complaints in the lot.Additional information was requested.The manufacturer internal reference number is: (b)(4).

Event Description

A nurse reported that after an intraocular lens (iol) was implanted, the patient experienced headache, dizziness and glare in near vision.The lens was exchanged for another lens of a different model and.5 diopters stronger power.Additional information was requested.

Manufacturer Narrative

The lens was not returned for evaluation.Only the carton , lens case and carton inserts were returned.The product investigation could not identify a root cause for the reported issues.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
• MDR Report Key: 8135060
• MDR Text Key: 129433499
• Report Number: 1119421-2018-01717
• 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: foreign,health professional
• Type of Report: Initial,Followup
• Report Date: 09/25/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/05/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2021
• Device Model Number: SND1T4
• Device Catalogue Number: SND1T4.255
• Device Lot Number: 12449297
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/22/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention