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

Model Number ZXR00

Device Problem Inadequacy of Device Shape and/or Size (1583)

Patient Problems Visual Impairment (2138); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

(b)(4).All pertinent information available to abbott medical optics has been submitted.

Event Description

It was reported that a zxr00 22.5 diopter intraocular lens (iol) was implanted into the right eye (od) of the patient on (b)(6) 2017.It was later explanted on (b)(6) 2017, because the patient could not see properly.There was incision enlargement but no vitrectomy, or sutures.The lens was replaced with the same model, but different, smaller diopter of 21.0.Reportedly, there was no patient injury and the patient is doing fine post-operatively.No further information was provided.

Manufacturer Narrative

Device available for evaluation? yes; returned to manufacturer on: 01/12/2018; device returned to manufacturer? yes.Device evaluation: the sample was returned to the manufacturer.Visual inspection was performed.Returned sample was cut in pieces most probably to make explant possible.Considering the condition of the lens additional analysis is not possible.The reported complaint cannot be confirmed.Manufacturing record review: manufacturing record review of the production order and related document revealed that the product was manufactured and released according to specification.There was no discrepancy found during the review.A search revealed that no similar complaints were received from this production order.Labeling review: the directions for use (dfu) was reviewed.The dfu adequately provides instructions and precautions for the proper use and handling of the product.Conclusion: based on the investigation results there is no indication of a product quality deficiency.All pertinent information available to johnson & johnson surgical vision, inc has been submitted.

• Brand Name: TECNIS SYMFONY
• Type of Device: MULTIFOCAL IOLS
• Manufacturer (Section D): ABBOTT MEDICAL OPTICS; santa ana CA
• MDR Report Key: 7162377
• MDR Text Key: 96332399
• Report Number: 9614546-2018-00011
• Device Sequence Number: 1
• Product Code: POE
• UDI-Device Identifier: 05050474579149
• UDI-Public: (01)05050474579149(17)211213
• Combination Product (y/n): N
• PMA/PMN Number: P980040
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Type of Report: Initial,Followup
• Report Date: 03/09/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/03/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Expiration Date: 12/13/2021
• Device Model Number: ZXR00
• Device Catalogue Number: ZXR00U0225
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/12/2018
• Date Manufacturer Received: 02/09/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 54 YR