MAUDE Adverse Event Report: JOHNSON & JOHNSON SURGICAL VISION, INC. TECNIS SYMFONY; MULTIFOCAL IOLS

Model Number	ZXR00
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Codes	Blurred Vision (2137); Visual Impairment (2138); No Code Available (3191)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Date of event: unknown, not provided, but the best estimate date is between (b)(6) 2017 and (b)(6) 2018.(b)(4).Attempts have been made to obtain missing information; however, to date, no response has been received.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Event or Problem Description
It was reported that a zxr00 14.5 diopter intraocular lens (iol) was implanted in the patient's right eye (od) on (b)(6) 2017.It was later explanted on (b)(6) 2018 due to a mechanical failure.Reportedly, there was no patient injury.No additional information was provided.
Additional Manufacturer Narrative
Device available for evaluation: yes, returned to manufacturer on: 03/21/2018, device returned to manufacturer: yes.Device evaluation: the product was returned to the manufacturing site for evaluation.Visual inspection at 12x microscope magnification showed that the loop tip is damaged, probably to make explant possible.There are no further anomalies.Manufacturing records review: the manufacturing records for the intraocular lens were reviewed.The product was manufactured and released according to specification.A search on complaints revealed that no similar complaints were received for this production order number.Labeling review: 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 johnson & johnson surgical vision, inc.Has been submitted.
Additional Manufacturer Narrative
Additional information received reported there was an incision enlargement made and that the patient is doing well post-operatively.The replacement lens was an aab00 13.5 diopter lens.Also, it was confirmed that ''mechanical failure'' meant that the patient was not able to visually adapt to the multi focal design of the symfony lens.The patient didn¿t think his vision was clear vision with the symfony.He complained of fuzzy, foggy, cloudy vision with reading, tv, and computer.No additional information was provided.(b)(4).All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.

• Brand Name: TECNIS SYMFONY
• Common Device Name: MULTIFOCAL IOLS
• Manufacturer (Section D): JOHNSON & JOHNSON SURGICAL VISION, INC.; santa ana CA 92705
• MDR Report Key: 7372581
• Report Number: 9614546-2018-00284
• Device Sequence Number: 1103647
• Product Code: POE
• UDI-Device Identifier: 05050474591738
• UDI-Public: (01)05050474591738(17)220921
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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: health professional,user faci
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/05/2018

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: 09/21/2022
• Device Model Number: ZXR00
• Device Catalogue Number: ZXR00U0145
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/21/2018
• Initial Date Received by Manufacturer: 02/26/2018
• Supplement Date Received by Manufacturer: 03/29/2018; 06/05/2018
• Initial Report FDA Received Date: 03/27/2018
• Supplement Report FDA Received Date: 03/30/2018; 06/05/2018
• 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