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

Model Number	ZXR00
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Visual Impairment (2138); No Code Available (3191)
Date of Event	07/24/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Date of event: exact date unknown/not provided.Best estimate date is between (b)(6) 2019-(b)(6) 2019.(b)(4).An attempt has been made to obtain missing information; however, no definitive response has been received.The device was manufactured at the (b)(4) which has been closed.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Event or Problem Description
It was reported that there was a power miss with a model zxr00 intraocular lens (iol).The lens was explanted and replaced with the same model, but higher diopter (22.0).No additional information was provided to johnson & johnson surgical vision.
Additional Manufacturer Narrative
Additional information: section d10: device available for evaluation? yes.Returned to manufacturer on: 2/10/20.Section h3: device returned to manufacturer ¿ yes.Device evaluation: a visual inspection under magnification revealed viscoelastic residue on the lens'' optic body and haptics.Additionally, the lens was observed to be cut in half, which is consistent with a lens that was handled during explant.Based on the return condition of the lens, no further evaluation could be performed.The complaint issue could not be confirmed, and no product deficiency could be identified.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.H3 other text : placeholder.
Additional Manufacturer Narrative
Additional information further information was provided and reported the patient had poor vision.There was no incision enlargement, unplanned sutures, or a vitrectomy required.The patient is doing well post-operatively.Additionally, the date of event was provided.The following sections have been updated accordingly: section b3: date of event: (b)(6) 2019.Section h6: patient code: 2138.Device evaluation: product evaluation has not been performed as the suspect product has not been received.The complaint issue reported could not be verified and no product deficiency could be identified.Manufacturing record review: the manufacturing records for the intraocular lens were reviewed.The product was manufactured according to specifications.The search revealed that no other complaint for this production order number has been received.Conclusion: as a result of the investigation 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
This correction mdr is being submitted to address inaccurate information in section f on the xml version of the previous submission caused by a software glitch in the transmission process.The internal non-conformance numbers for this software issue are (b)(4) and capa-010215.

• Brand Name: TECNIS SYMFONY
• Common Device Name: MULTIFOCAL IOLS
• Manufacturer (Section D): JOHNSON & JOHNSON SURGICAL VISION, INC.; 1700 e st andrew place; santa ana CA 92705
• MDR Report Key: 9541890
• Report Number: 2020664-2020-00002
• Device Sequence Number: 14055617
• Product Code: POE
• UDI-Device Identifier: 05050474579095
• UDI-Public: (01)05050474579095(17)230825
• Combination Product (Y/N): Y
• 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: 2019
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 11/04/2020
• Report Date (Section F): 01/01/2005

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: Health Professional
• Device Expiration Date: 08/25/2023
• Device Model Number: ZXR00
• Device Catalogue Number: ZXR00U0200
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/10/2020
• Was the Report Sent to FDA?: No
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 12/06/2019
• Supplement Date Received by Manufacturer: 01/07/2020; 02/13/2020; 10/25/2020
• Initial Report FDA Received Date: 01/02/2020
• Supplement Report FDA Received Date: 01/30/2020; 03/12/2020; 11/04/2020
• 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
• Patient Age: 72 YR
• Date Report Sent to FDA: 01/01/2005