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

Model Number MA60BM

Device Problem Patient-Device Incompatibility (2682)

Patient Problem Visual Impairment (2138)

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

An ophthalmologist reported that in a literature article abstract titled decreased visual acuity resulting from glistening and sub-surface nano-glistening formation in intraocular lenses: a retrospective analysis of 5 cases.According to the authors, there were 5 patients whose visual acuity improved when the intraocular lenses (iols) were exchanged because of severe glistening and subsurface nano-glistening (ssng).All affected iols had been originally implanted over a range of 6-15 years prior to the iol exchange.Light transmission was decreased in all affected lenses compared to similar control iol.The authors concluded that although only a few reports of cases in which glistening and ssng have progressed to the level of decreased visual function have been published, the likelihood is that this phenomena will increase as the severity and incidence of these inclusions have been shown to increase with time.Appropriate evaluations of visual function in such patients are needed and consideration should be given to iol exchange in symptomatic patients.No further information is expected.

Manufacturer Narrative

Corrected information - literature article abstract attached.(b)(4).

Manufacturer Narrative

It was identified the value of was transmitted as null.This supplement is being filed to correct the value from null to adverse event and product problem.The manufacturer internal reference number is: (b)(4).

• Brand Name: ACRYSOF MULTIPIECE 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: 7674700
• MDR Text Key: 113578139
• Report Number: 1119421-2018-00897
• Device Sequence Number: 1
• Product Code: HQL
• Combination Product (y/n): N
• Reporter Country Code: BB
• PMA/PMN Number: P930014
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Home Health Aide
• Type of Report: Initial,Followup,Followup
• Report Date: 11/12/2018

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 Model Number: MA60BM
• Device Catalogue Number: MA60BM.XXX
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/12/2018
• Initial Date FDA Received: 07/10/2018
• Supplement Dates Manufacturer Received: 07/12/2018; 10/29/2018
• Supplement Dates FDA Received: 07/17/2018; 11/12/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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): Other; Required Intervention