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

Model Number ZXR00

Device Problem Incorrect Measurement (1383)

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

Event Date 10/25/2016

Event Type  Injury  

Manufacturer Narrative

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

Event Description

It was reported that after implantation of a symfony lens into patient left eye, it resulted in the patient having a poor visual acuity 20/200) and a - 2.0 refraction.Patient could not see at distance and is affecting their daily activities.Patient is unhappy as he is unable to see on the computer.The patient's left eye had -275+150x005 20/20 and the physician aimed for a plano.The physician checked the biometry using both a-scan and iol master and both looked accurate with no red flags.The patient is seeing 20/20 up close (around 40cm) but could not see anything beyond 40cm (20/150 refraction).Iol master showed +0.69 diopter of cylinder pre-op but post-op patient is refracting at +1.5 diopter of cylinder.The lens was explanted and replaced with a zcb00 lens.

Manufacturer Narrative

Device evaluation: the device was not returned to the manufacturer for evaluation.Device inspection could not be performed, therefore the reported complaint could not be verified.Manufacturing records were reviewed and the lens was manufactured according to specification.A search on complaints revealed no similar complaints were received for this order number to date.The directions for use (dfu) was reviewed.The dfu adequately provides instructions and precautions for the proper use and handling of the intraocular lenses.Based on the investigation results there is no indication of a product quality deficiency.All pertinent information available to the manufacturer 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: pam mcclain ; 1700 east st. andrew place; santa ana, CA 92705 ; 7142478243
• MDR Report Key: 6165559
• MDR Text Key: 62103263
• Report Number: 9614546-2016-00672
• Device Sequence Number: 1
• Product Code: POE
• UDI-Device Identifier: 05050474575646
• UDI-Public: (01)05050474575646(17)201202
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: P980040
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 02/03/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/11/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Expiration Date: 12/02/2020
• Device Model Number: ZXR00
• Device Catalogue Number: ZXR00I0220
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/11/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/02/2015
• 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
• Patient Outcome(s): Required Intervention
• Patient Age: 76 YR