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

Model Number SN6AD1

Device Problems Bent (1059); Break (1069)

Patient Problem No Code Available (3191)

Event Date 05/20/2016

Event Type  Injury  

Manufacturer Narrative

A sample device was not returned for analysis.Results from the product history record review indicated the iol met release criteria.Root cause cannot be identified at this time.There have been no other complaints reported in the lot number.Additional information was requested.(b)(4).

Event Description

A surgeon reported that one day after an intraocular lens (iol) was implanted, it was noted to be decentered due to a bent haptic.The lens was explanted that same day.Additional information was requested.

Manufacturer Narrative

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

Event Description

A company representative gave clarifying information that explained the event timeline differently than what was initially reported.During an intraocular lens (iol) implant procedure, the haptic of the lens bent., but was left implanted.During the one day postoperative visit, the haptic was noted to be broken and decentered.The lens was then exchanged six days later.

Event Description

A company representative gave clarifying information that explained the event timeline differently.During an intraocular lens (iol) implant procedure, the haptic of the lens bent, but was left implanted.During the one day postoperative visit, the haptic was noted to be broken and decentered.The lens was then exchanged six days later.

Manufacturer Narrative

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

• Brand Name: ACRYSOF IQ RESTOR SINGLEPIECE IOL
• Type of Device: LENS, MULTIFOCAL INTRAOCULAR
• 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: eddie darton, md, jd ; 6201 south freeway; mail stop ab2-6; fort worth, TX 76134 ; 8175686660
• MDR Report Key: 5726744
• MDR Text Key: 47452982
• Report Number: 9612169-2016-00075
• Device Sequence Number: 1
• Product Code: MFK
• Combination Product (y/n): N
• Reporter Country Code: AR
• PMA/PMN Number: P040020
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 07/01/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/15/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2020
• Device Model Number: SN6AD1
• Device Catalogue Number: SN6AD1X265
• Device Lot Number: 21126471
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/29/2016
• Date Device Manufactured: 02/26/2015
• 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; Other