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

Model Number	ZXR00
Medical Device Problem Codes	No Apparent Adverse Event (3189); Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Codes	Blurred Vision (2137); No Code Available (3191)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Sex/gender: unknown/not provided.Date of event: exact date unknown/not provided.Best estimate date is between (b)(6) 2018 - (b)(6) 2019.(b)(4).An attempt has been made to obtain missing information; however, no definitive 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 an intraocular lens (iol) had a mechanical failure, therefore, the lens was explanted and removed in 1 piece.An incision enlargement was required.There was no other patient injury.No additional information was provided to johnson & johnson surgical vision.
Additional Manufacturer Narrative
Further information was provided.The reason for the lens explant was due to the patient reporting symptoms of a constant visual film, blur over distance and near vision all the time as if he was looking through water all the time.Prescription spectacle correction did not resolve the symptoms.The replacement lens was a different model and lower diopter.The patient was doing well post-operatively.The following sections have been updated accordingly: sex/gender: male.Patient code: 2137.Device code: 3189.Device evaluation: the returned sample was received within the biohazard resealable bag contained with daisy wheel of its replacement lens.Visual inspection of the returned daisy wheel revealed that the lens was not present in the daisy wheel nor the biohazard plastic bag.The complaint issue reported could not be verified.Manufacturing record review: the manufacturing records for the intraocular lens were reviewed.The product was manufactured according to specifications.The search revealed that no similar 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 nr-0148919 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: 8891639
• Report Number: 3011852734-2019-00167
• Device Sequence Number: 205581
• Product Code: POE
• UDI-Device Identifier: 05050474579095
• UDI-Public: (01)05050474579095(17)230105
• Combination Product (Y/N): Y
• 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: 2018
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/11/2020
• 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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 01/05/2023
• Device Model Number: ZXR00
• Device Catalogue Number: ZXR00U0200
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 07/17/2019
• Supplement Date Received by Manufacturer: 08/21/2019; 10/25/2020
• Initial Report FDA Received Date: 08/14/2019
• Supplement Report FDA Received Date: 09/18/2019; 11/12/2020
• 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
• Date Report Sent to FDA: 01/01/2005