MAUDE Adverse Event Report: ALCON RESEARCH, LLC - HUNTINGTON ACRYSOF ASPHERIC UV ABSORBING SINGLEPIECE IOL; INTRAOCULAR LENS

Model Number SA60WF

Device Problem Structural Problem (2506)

Patient Problem Failure of Implant (1924)

Event Type  Injury  

Manufacturer Narrative

Evaluation summary: the product was not returned for analysis.The complaint history and product history records could not be reviewed because the reporting facility did not provide a lot number or any identification traceable to the manufacturing documentation.The product investigation could not identify a root cause.(b)(4).

Event Description

A physician reported that following intraocular lens (iol) implant procedures, there was anterior capsular membrane growth over the optics of both types of lenses within 2 weeks of implantation.He describes it to be more "feathery" in structure, rather than as defined as anterior capsular phimosis.The membrane growth has occurred in approximately 3 of 20 cases and in some cases has required yag laser treatment.Additional information was provided by the physician, who reported " i¿ve had a handful of these funny anterior capsular membranes (not phimosis necessarily, more of a feathery membrane extending centrally from the edge of the rhexis, 360 degrees)".The physician confirmed his observations as lens epithelial cell on growth and the doctor responded "yes, looking at a couple pictures online this is certainly what it is.Generally i have noticed it within a couple weeks post-operatively.I¿ve had a handful over the last couple years and lasered a couple of them, not knowing it would regress and i of course was worried about the visual axis.They came off easily with yag as well." there are two medical device reports associated with these reported event.This report is for one of two lens models.

• Brand Name: ACRYSOF ASPHERIC UV ABSORBING SINGLEPIECE IOL
• Type of Device: INTRAOCULAR LENS
• 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: cindy milam ; 6201 south freeway; mail stop ab2-6; fort worth, TX 76134 ; 8176152231
• MDR Report Key: 8728715
• MDR Text Key: 149052455
• Report Number: 1119421-2019-01001
• Device Sequence Number: 1
• Product Code: HQL
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: P930014
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 06/24/2019

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?: No
• Device Operator: Health Professional
• Device Model Number: SA60WF
• Device Catalogue Number: SA60WF.XXX
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/28/2019
• Initial Date FDA Received: 06/24/2019
• 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