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

Model Number	ZXT150
Medical Device Problem Code	Inadequacy of Device Shape and/or Size (1583)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Code Available (3191)
Date of Event	11/21/2017
Type of Reportable Event	Serious Injury
Additional 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 or Problem 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.
Additional 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.
Additional 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.
Additional 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
• Common Device Name: MULTIFOCAL IOLS
• Manufacturer (Section D): ABBOTT MEDICAL OPTICS; santa ana CA
• MDR Report Key: 7223354
• Report Number: 9614546-2018-00086
• Device Sequence Number: 16642925
• Product Code: POE
• UDI-Device Identifier: 05050474605152
• UDI-Public: (01)05050474605152(17)220828
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: P980040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 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
• Operator of Device: Physician
• Device Expiration Date: 08/28/2022
• Device Model Number: ZXT150
• Device Catalogue Number: ZXT150U175
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/02/2018
• Supplement Date Received by Manufacturer: 01/29/2018; 03/05/2018; 04/06/2018
• Initial Report FDA Received Date: 01/26/2018
• Supplement Report FDA Received Date: 02/25/2018; 04/02/2018; 05/03/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention