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

Model Number ZXR00

Device Problem Kinked (1339)

Patient Problem No Patient Involvement (2645)

Event Date 09/29/2016

Event Type  malfunction  

Manufacturer Narrative

All pertinent information available to abbott medical optics has been submitted.

Event Description

It was reported that a kinked optic was found prior to handling the lens.The optic came kinked in the case; was kinked prior to handling.No patient contact.No additional information was provided to abbott medical optics.

Manufacturer Narrative

Corrected data: on the initial report device available for evaluation was incorrectly indicated as no.It should have been indicated as yes.It has been corrected in this filing.Device evaluation: the product was received in a lens case.Visual inspection with the unaided eye shows the lens is contaminated, dust particles are present.This is expected as the lens was transported from controlled environment during manufacturing to a non-sterile, non-environmental controlled area.The lens was inspected by a qualified inspector using a 12x magnification.No anomalies were found.The reported issue was not verified.Manufacturing records review: the manufacturing records for the product were reviewed.The product was manufactured and released according to specifications.A search revealed that no additional similar complaints for this order number have been received.Labeling review: the labeling review was completed and revealed that the directions for use (dfu) provide the customer with proper usage instructions and guidelines.No labeling changes are required.Conclusion: as a result of the investigation, there is no indication of a product quality deficiency.All pertinent information available to abbott medical optics has been submitted.

• Brand Name: TECNIS SYMFONY
• 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: pamela mcclain ; 1700 east st. andrew place; santa ana, CA 92705 ; 7142478243
• MDR Report Key: 6062545
• MDR Text Key: 58602357
• Report Number: 9614546-2016-00551
• Device Sequence Number: 1
• Product Code: POE
• UDI-Device Identifier: 05050474591721
• UDI-Public: (01)05050474591721(17)210811
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P980040
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 12/19/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/27/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 08/11/2021
• Device Model Number: ZXR00
• Device Catalogue Number: ZXR00U0140
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 10/25/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/24/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/11/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: 1MTEC30 CARTRIDGE, LOT # UNKNOWN