MAUDE Adverse Event Report: ABBOTT MEDICAL OPTICS TECNIS SYMFONY TORIC; MULTIFOCAL IOLS

Model Number ZXT225

Device Problem Crack (1135)

Patient Problem No Patient Involvement (2645)

Event Date 07/04/2016

Event Type  malfunction  

Manufacturer Narrative

The lens was not implanted; therefore, not explanted.(b)(6).The lens was returned to the manufacturing site for evaluation.The lens was cleaned and was inspected using 12x microscope magnification.A small crack was seen on the edge of the intraocular lens.The crack is within the acceptable manufacturing cosmetic specifications.The manufacturing records for the intraocular lens were reviewed.The product was manufactured and released according to specification.A search revealed that no additional complaints for this order number have been received.As a result of the investigation there is no indication of a product quality deficiency.The customer's reported event, faulty lens, could not be confirmed in the returned lens sample.All pertinent information available to abbott medical optics has been submitted.

Event Description

It was reported that an intraocular lens (iol) was faulty per the surgeon.There was no patient involvement.No further information was provided.The lens was returned to the manufacturing site and a small crack was seen on the edge of the lens.No further information was provided.

• Brand Name: TECNIS SYMFONY TORIC
• Type of Device: MULTIFOCAL IOLS
• Manufacturer (Section D): ABBOTT MEDICAL OPTICS; santa ana CA
• Manufacturer (Section G): ABBOTT MEDICAL OPTICS INC.; van swietenlaan 5; groningen 9728 NX; NL 9728 NX
• Manufacturer Contact: pam mcclain ; 1700 east st. andrew place; santa ana, CA 92705 ; 7142478243
• MDR Report Key: 6086081
• MDR Text Key: 59462712
• Report Number: 9614546-2016-00578
• Device Sequence Number: 1
• Product Code: POE
• UDI-Device Identifier: 05050474574588
• UDI-Public: (01)05050474574588(17)200730
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: P980040
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/08/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/08/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 07/30/2020
• Device Model Number: ZXT225
• Device Catalogue Number: ZXT225I190
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/26/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/12/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/30/2015
• 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