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

Model Number SA60AT

Device Problem Insufficient Information (3190)

Patient Problems Adhesion(s) (1695); Hyperemia (1904); Blurred Vision (2137)

Event Date 05/15/2018

Event Type  Injury  

Manufacturer Narrative

Product evaluation: the product was not returned.Product history records were reviewed and the documentation indicated the product met release criteria.The product investigation could not identify a root cause.Information was provided that the lens was implanted on (b)(6) 2018.On (b)(6) 2018 patients reported symptoms were observed.The diagnosis was intraocular lens rejection.Treatment was provided and the symptoms resolved after 2 days.There have been no other complaints reported in the lot number.(b)(4).

Event Description

A health authority reported blurred vision, conjunctival hyperemia and a sluggish pupil with adhesions in an eye following an intraocular lens (iol) implant procedure.The patient was treated with medications and the symptoms improved.The lens remains implanted.

• Brand Name: ACRYSOF SINGLEPIECE IOL
• Type of Device: INTRAOCULAR LENS
• 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: 7864016
• MDR Text Key: 119808420
• Report Number: 1119421-2018-01302
• Device Sequence Number: 1
• Product Code: HQL
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: P930014
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 09/11/2018

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?: No
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2020
• Device Model Number: SA60AT
• Device Catalogue Number: SA60ATC230
• Device Lot Number: 12400109
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 08/17/2018
• Initial Date FDA Received: 09/11/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/30/2015
• 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): Required Intervention