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

Model Number ZXT150

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

Patient Problems No Consequences Or Impact To Patient (2199); No Code Available (3191)

Event Date 11/21/2017

Event Type  Injury  

Manufacturer Narrative

Date of event: unknown, not provided, but the best estimate date is during 2017.(b)(4).Attempts have been made to obtain missing information; however, to date, no response has been received.All pertinent information available to abbott medical optics has been submitted.

Event Description

It was reported that a tecnis symfony toric intraocular lens (model zxt150, +17.5 diopter) was explanted in a secondary procedure because patient turned out to have less cylinder than was predicted.Tecnis symfony multifocal intraocular lens (model zxr00 with +16.5 diopter) was implanted as the replacement lens for the patient.No further information was provided.

Manufacturer Narrative

Additional information: additional information received reported that an explant has not been done yet, but the anticipated date of surgery is (b)(6) 2018.No additional information was provided.(b)(4).All pertinent information available to abbott medical optics has been submitted.

Manufacturer Narrative

Device evaluation: the product testing could not be performed as the product was not returned.The reported complaint cannot be confirmed.Manufacturing record review: the manufacturing process record was evaluated and no deviation was found during process related to the complaint issue reported.There was no discrepancy found during the mrr (manufacturing record review).The product was manufactured and released according to the specifications.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.

Manufacturer Narrative

Date of event: (b)(6) 2017.Description of event (additional information): per account, there were no pre-existing condition.There was no patient injury, vitrectomy, incision enlargement or surgical intervention.Patient was doing fine post-surgery.The product will not be returned, as the lens was not kept.If implanted; (b)(6) 2017.If explanted; (b)(6) 2018.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.

• Brand Name: TECNIS SYMFONY TORIC
• Type of Device: MULTIFOCAL IOLS
• Manufacturer (Section D): ABBOTT MEDICAL OPTICS; santa ana CA
• MDR Report Key: 7223354
• MDR Text Key: 98406794
• Report Number: 9614546-2018-00086
• Device Sequence Number: 1
• Product Code: POE
• UDI-Device Identifier: 05050474605152
• UDI-Public: (01)05050474605152(17)220828
• Combination Product (y/n): N
• PMA/PMN Number: P980040
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 05/03/2018

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: 08/28/2022
• Device Model Number: ZXT150
• Device Catalogue Number: ZXT150U175
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 01/02/2018
• Initial Date FDA Received: 01/26/2018
• Supplement Dates Manufacturer Received: 01/29/2018; 03/05/2018; 04/06/2018
• Supplement Dates FDA Received: 02/25/2018; 04/02/2018; 05/03/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention