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

Model Number SN60WF

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Visual Impairment (2138); Visual Disturbances (2140)

Event Type  malfunction  

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.Additional information has been requested.(b)(4).

Event Description

A health professional reported that after an intraocular lens (iol) implant surgery in the left eye, a lens presented with glistenings.The patient had the initial surgery in 2010.The patient is complaining that the glistening is interfering with her vision.Additional information has been requested.

Manufacturer Narrative

The product was not returned.Evaluation of provided photos: there is a fine punctate pattern beneath the optic surface.The image is consistent with glistenings.However, it is difficult to determine which iol was implanted.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.There is a fine punctate pattern beneath the optic surface.The image is consistent with glistenings.However, it is difficult to determine which iol was implanted.The product investigation could not identify a root cause for the reported complaint.The clinical impact of the described photo observations cannot be determined from a picture assessment.The manufacturer internal reference number is: (b)(4).

• Brand Name: ACRYSOF IQ NATURAL 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
• MDR Report Key: 8719007
• MDR Text Key: 148823804
• Report Number: 9612169-2019-00158
• Device Sequence Number: 1
• Product Code: HQL
• Combination Product (y/n): N
• PMA/PMN Number: P930014
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Type of Report: Initial,Followup
• Report Date: 08/27/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: SN60WF
• Device Catalogue Number: SN60WF.XXX
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 06/12/2019
• Initial Date FDA Received: 06/20/2019
• Supplement Dates Manufacturer Received: 08/20/2019
• Supplement Dates FDA Received: 08/27/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: UNSPECIFIED IOL