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

Model Number ZXT375

Device Problems Incorrect Measurement (1383); Appropriate Term/Code Not Available (3191)

Patient Problem No Code Available (3191)

Event Date 10/24/2016

Event Type  Injury  

Manufacturer Narrative

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

Event Description

It was initially reported that the doctor likes the lens and has had success with other patients with the lens but was planning to explant the lens as the axis has been flipped on this male patients left eye, resulting in 1.5d of residual cylinder.He mentions his wound does not create a large astigmatism shift, but the pre-op pentacam may have shown some artifact astigmatism.He believes using the symfony toric calculator when picking the cylinder correction power would have been beneficial.He will replace this symfony toric with a tecnis toric lens.Further information confirmed the explant did occur due to the toric axis flipped.The physician picked the wrong cylinder correction power because he did not use the toric calculator.Additionally, the physician noted that the patient had a 20/20 refraction.The patient has recovered.No other information was provided.

Manufacturer Narrative

Device available for evaluation ¿ yes, returned to manufacturer on 12/16/2016.Device returned to manufacturer ¿ yes.Device evaluation: the intraocular lens (iol) was returned to the manufacturer.Visual inspection using 12x magnification and does not show anomalies.The condition of the lens is consistent with an explanted product.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 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: 6105094
• MDR Text Key: 59967185
• Report Number: 9614546-2016-00606
• Device Sequence Number: 1
• Product Code: POE
• UDI-Device Identifier: 05050474606944
• UDI-Public: (01)05050474606944(17)210718
• 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: 01/31/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/16/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Expiration Date: 07/18/2021
• Device Model Number: ZXT375
• Device Catalogue Number: ZXT375U185
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/16/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/09/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/18/2016
• 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