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

Model Number SN6AT4

Device Problem Material Twisted/Bent (2981)

Patient Problem Perforation (2001)

Event Date 01/24/2018

Event Type  Injury  

Manufacturer Narrative

The product was returned for analysis.Investigation including root cause analysis is in progress.A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when additional reportable information becomes available.Results from the product history record review indicated the product met release criteria.There have been no other complaints reported in the lot number.(b)(4).

Event Description

A nurse reported that when the lens was inserted during a cataract removal with intraocular lens (iol) implant procedure, the leading haptic curled backwards and didn't come around, making a hole in the capsule.The lens was then removed and another lens inserted.Additional information has been requested.

Manufacturer Narrative

Product evaluation: the product was returned for analysis and a damaged haptic was observed.Additional observations were as follows: the iol was returned in an unknown specimen container.Solution was dried on both surfaces of the optic and one haptic.One haptic is broken/torn and was not returned.The optic was torn/split-cut dividing the iol in two (2) and was scratched/marked-rejectable.We are unable to determine the root cause for the reported complaint.The returned iol showed evidence of possible handling by the customer due to the presence of solution.In addition to this, all iols are 100% cosmetically inspected as per approved manufacturing procedures and the observed damage (haptic broken/torn) would not meet our current release criteria.Based on these investigation findings, we are unable to verify if the iol contributed to the event.All product and batch history records are quality reviewed prior to product release.(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: 7302995
• MDR Text Key: 101165938
• Report Number: 9612169-2018-00034
• Device Sequence Number: 1
• Product Code: MJP
• Combination Product (y/n): N
• Reporter Country Code: NZ
• PMA/PMN Number: P930014
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 05/31/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/28/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2021
• Device Model Number: SN6AT4
• Device Catalogue Number: SN6AT4.230
• Device Lot Number: 21181664
• Other Device ID Number: 00380652250481
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/26/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/01/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/12/2017
• 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