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

Model Number SA60AT

Device Problem Defective Device (2588)

Patient Problems Edema (1820); Swelling (2091); Visual Impairment (2138)

Event Date 12/01/2016

Event Type  Injury  

Manufacturer Narrative

A sample device was not returned for analysis.Complaint history and product history records were reviewed and documentation indicated the product met release criteria.Root cause has not been identified.There have been no other complaints reported in the lot number.Additional information has been requested.The manufacturer internal reference number is: (b)(4).

Event Description

A patient reported that three months following an intraocular lens (iol) implant procedure, the lens was determined to be defective.The iol was removed four months following the initial procedure, but a replacement lens was not implanted.Approximately two and a half months later, a corneal specialist sewed in a replacement lens, followed by a dsek (descemet's stripping endothelial keratoplasty) corneal transplant three months after the replacement lens was implanted.The patient reported she sees a retina specialist for edema caused by multiple surgeries.She also stated that her vision has not returned to her pre-surgical level and has had to retire from her job due to insufficient vision.A follow up to the surgeon was performed who reported the patient had an extremely short eye (+10.00 hyperopic) preoperatively.Nine days postoperative, another physician in the group noted the patient had a pre-retinal membrane, but there was a question of a membrane irregularity on the posterior surface of the lens.The surgeon agreed with the physician and scheduled a procedure to either clear the backside of the iol , or perform an iol exchange.During the secondary procedure (4 months postoperative), the lens could not be polished or cleaned posteriorly, so it was removed from the patient's eye.There was not adequate support for a bag or sulcus lens after the iol removal, so the patient was left aphakic.The patient was referred to a corneal specialist who sewed in an iol seven months postoperative to the initial procedure.Three months later the patient had a corneal transplant due to corneal swelling.The patient is also under the care of a retina specialist for her pre-retinal membrane.

• 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: 7942801
• MDR Text Key: 123065891
• Report Number: 1119421-2018-01448
• Device Sequence Number: 1
• Product Code: HQL
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P930014
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,health professional
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 10/08/2018

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?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2021
• Device Model Number: SA60AT
• Device Catalogue Number: SA60AT.400
• Device Lot Number: 12473660
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 09/11/2018
• Initial Date FDA Received: 10/08/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/18/2016
• 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: 61 YR