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

Model Number ZXT300

Device Problems Incorrect Measurement (1383); Inadequacy of Device Shape and/or Size (1583); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Blurred Vision (2137); No Code Available (3191)

Event Date 04/28/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).All pertinent information available to the manufacturer has been submitted.

Event Description

It was reported that a zxt300 12.5 diopter intraocular lens was explanted because patient's vision was not clear.Patient could not see or read small print.No further information was provided.

Manufacturer Narrative

Through follow up it was learned that the lens was explanted from a female patient's left eye.The lens was replaced with the same model lens with a lower diopter power.There was no incision enlargement, no vitrectomy, no sutures and no patient post-op injury reported.(b)(6).Gender/sex: female.If implanted, give date: (b)(6) 2017.(b)(4).All pertinent information available to the manufacturer has been submitted.

Manufacturer Narrative

Corrected data: supplemental mdr follow up #1 had an incorrect device code entered.(b)(4) was reported and it should have been coded as (b)(4).(b)(4).Device available for evaluation? yes, returned to manufacturer on 6/13/2017.Device returned to manufacturer? yes.Device evaluation : the device was returned to the manufacturer.Visual inspection with the unaided eye shows the product is cut in pieces, most probably to make explant possible.Considering the condition of the lens additional analysis is not possible.The customer's reported event could not be confirmed in the returned lens sample.Manufacturing records were reviewed and the lens was manufactured according to specification.A search on complaints revealed that no similar complaints were received for this production order number.The directions for use (dfu) was reviewed.The dfu adequately provides instructions and precautions for the proper use and handling of the device.Based on the investigation results there is no indication of a product quality deficiency.All pertinent information available to the manufacturer has been submitted.

Manufacturer Narrative

Investigation clarification added operational problem as a failure mode.No additional information was provided.All pertinent information available to abbott medical optics has been submitted.

• 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: 6590035
• MDR Text Key: 75915959
• Report Number: 9614546-2017-00470
• Device Sequence Number: 1
• Product Code: POE
• UDI-Device Identifier: 05050474606234
• UDI-Public: (01)05050474606234(17)220130
• 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: health professional,user faci
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 08/30/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/25/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Expiration Date: 01/30/2022
• Device Model Number: ZXT300
• Device Catalogue Number: ZXT300U125
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/13/2017
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/07/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/30/2017
• 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): Required Intervention
• Patient Age: 64 YR