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 Problem No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

Unknown, information not provided.Gender/sex: unknown, information not provided.Date of event: unknown, not provided, but the best estimate date is between (b)(6) 2017 and (b)(6) 2017.Explant.Unspecified patient complaints about the lens.All pertinent information available to abbott medical optics has been submitted.

Event Description

It was reported that a zxr00 21.0 diopter intraocular lens (iol) was implanted in the left eye (os) on (b)(6) 2017.It was later explanted on (b)(6) 2017, because of unspecified patient complaints about the lens.The replacement lens was the same model, but different diopter of 20.0.Reportedly, the patient's visual acuity was 20/50 after the initial cataract surgery and refracted at -0.75 20/20- post op.J1 @ 16.Lens was explanted and no adverse effects were reported.No additional information was provided.

Manufacturer Narrative

The product was not returned to the manufacturing site.Therefore, product testing could not be performed and the customer¿s reported complaint could not be verified.The manufacturing records for the product was reviewed.The product was manufactured and released according to specification.A search on complaints revealed that no similar complaints have been received for this production order number.The directions for use (dfu) was reviewed.The dfu adequately provides instructions and precautions along with warnings for the proper use and handling of the device.As a result of the investigation there is no indication of a product quality deficiency and the reported issue could not be verified.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 92705
• 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: 7136339
• MDR Text Key: 95452944
• Report Number: 9614546-2017-01251
• Device Sequence Number: 1
• Product Code: POE
• UDI-Device Identifier: 05050474579118
• UDI-Public: (01)05050474579118(17)220906
• 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: 01/25/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Expiration Date: 09/06/2022
• Device Model Number: ZXR00
• Device Catalogue Number: ZXR00U0210
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/21/2017
• Initial Date FDA Received: 12/20/2017
• Supplement Dates Manufacturer Received: 01/02/2018
• Supplement Dates FDA Received: 01/26/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/06/2017
• 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