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

Model Number SN6AT3

Device Problems Break (1069); Torn Material (3024)

Patient Problems Failure of Implant (1924); Capsular Bag Tear (2639)

Event Type  Injury  

Manufacturer Narrative

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

Event Description

A nurse reported that during an intraocular lens (iol) implant procedure, the iol was noticed to be torn/broken after insertion into the eye, and was removed during the initial procedure.A posterior capsular tear also occurred, and the surgery was completed with a new lens placed in the sulcus.The reporter indicated that the surgeon stated he "pushed a little harder" during the insertion.Additional information has been requested.

Manufacturer Narrative

The customer indicated the use of a viscoelastic which is not qualified for the iol, cartridge and handpiece combination used.The reported complaint was not observed as no sample was returned for analysis; however, based on the information provided by the customer, the most likely root cause is failure to follow the directions for use (dfu), as the surgeon indicated the use of non-qualified product combination.The use of non-qualified combinations may result in delivery issues and/or damage.The manufacturer internal reference number is: (b)(4).

• Brand Name: ACRYSOF IQ TORIC SINGLEPIECE IOL
• Type of Device: LENS, INTRAOCULAR, TORIC OPTICS
• 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: nadia bailey ; 6201 south freeway; mail stop ab2-6; fort worth, TX 76134 ; 8176152230
• MDR Report Key: 6740465
• MDR Text Key: 80921397
• Report Number: 9612169-2017-00143
• Device Sequence Number: 1
• Product Code: MJP
• 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: health professional
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 10/26/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/25/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2020
• Device Model Number: SN6AT3
• Device Catalogue Number: SN6AT3.290
• Device Lot Number: 21143915
• Other Device ID Number: 00380652250078
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/19/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/12/2015
• 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
• Treatment: MONARCH III D CARTRIDGE; MONARCH III IOL DELIVERY SYSTEM; PROVISC OVD
• Patient Outcome(s): Other