MAUDE Adverse Event Report: ALCON LABORATORIES IRELAND LTD. ACRYSOF SINGLEPIECE IOL; INTRAOCULAR LENS

Model Number SA60AT

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Itching Sensation (1943); Loss of Vision (2139); Burning Sensation (2146); Discomfort (2330)

Event Date 08/19/2013

Event Type  Injury  

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 consumer daughter reported that following an intraocular lens (iol) implant procedure approximately 5 years ago, the consumer is experiencing discomfort, burning and itching in one eye as if the lens were dislocated.She reported that the discomfort is persistent and the dry eye symptoms have worsened.Additional information was provided by the consumer's daughter, who reported that the consumer is losing vision and is losing the retina.The consumer is currently being treated with an eye lubricant gel and will be seeing a retinal specialist.

Manufacturer Narrative

The manufacturer internal reference number is: (b)(4).

Event Description

Further information was provided that the patient had a capsulotomy and vision is recovered.Reporter clarifies that patient can see with 30% of vision.

Manufacturer Narrative

An attached picture was reviewed by a company physician.The intended object to show in the picture can not be determined.The root cause for the reported complaint could not be determined.A malfunction has not been indicated or information provided that the lens was the cause of the event.All product and batch history records are quality reviewed prior to product release.The manufacturer internal reference number is: (b)(4).

• Brand Name: ACRYSOF SINGLEPIECE IOL
• Type of Device: INTRAOCULAR LENS
• Manufacturer (Section D): ALCON LABORATORIES IRELAND LTD.; cork business&technology park; model farm road; cork 00000 ; EI 00000
• Manufacturer (Section G): ALCON LABORATORIES IRELAND LTD.; cork business&technology park; model farm road; cork 00000 ; EI 00000
• Manufacturer Contact: bryan blake ; 6201 south freeway; mail stop ab2-6; fort worth, TX 76134 ; 8176152230
• MDR Report Key: 7683644
• MDR Text Key: 113865237
• Report Number: 9612169-2018-00102
• Device Sequence Number: 1
• Product Code: HQL
• Combination Product (y/n): N
• Reporter Country Code: CI
• PMA/PMN Number: P930014
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other
• Reporter Occupation: Patient Family Member or Friend
• Type of Report: Initial,Followup,Followup
• Report Date: 10/03/2018

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: 06/30/2017
• Device Model Number: SA60AT
• Device Catalogue Number: SA60AT.210
• Device Lot Number: 21061305
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 06/12/2018
• Initial Date FDA Received: 07/12/2018
• Supplement Dates Manufacturer Received: 08/07/2018; 09/06/2018
• Supplement Dates FDA Received: 08/31/2018; 10/03/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/10/2012
• 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
• Patient Age: 87 YR