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

Model Number	ZXT300
Medical Device Problem Codes	Break (1069); Scratched Material (3020); Unintended Movement (3026)
Health Effect - Clinical Codes	Blurred Vision (2137); No Code Available (3191)
Date of Event	06/07/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Event or Problem Description
It was reported that a model zxt300 intraocular lens (iol) was explanted from the patient¿s left eye due to the patient experiencing blurry vision one day post-implant.Additional information received stated slightly wrong power and orientation issue (iol rotated), and the lens had a scratch on it.When the patient presented on (b)(6) 2019 the axis of the iol was at 75 degrees.The replacement lens is a different model (zxt150), but same diopter and was placed in the patient¿s eye at 14 degrees.There was no incision enlargement, no vitrectomy, no sutures required.Patient outcome is reported to be excellent.No other information was provided.
Additional Manufacturer Narrative
Corrected data: in the initial report, section h6: patient code: 3191: unexpected post-op refraction, was inadvertently missed.Section h6: patient code: 3191: unexpected post-op refraction.Additional information: section d10: device available for evaluation? yes.Returned to manufacturer on: oct 23, 2019.Section h3: device returned to manufacturer? yes.Device evaluation: on october 23, 2019 the return sample was received.The product was received dry in a jar.Visual inspection with the unaided eye shows the product is cut in pieces, most probably to make explant possible.Considering the condition of the lens additional analysis is not possible.The complaint cannot be confirmed.Manufacturing record review: the manufacturing process record was evaluated and revealed that the product was manufactured and released according to specifications.A search revealed that no similar complaints were received from this production order.Conclusion: 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.H3 other text: placeholder.
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 TORIC
• 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: 9200316
• Report Number: 9614546-2019-00976
• Device Sequence Number: 10874664
• Product Code: MFK
• UDI-Device Identifier: 05050474606449
• UDI-Public: (01)05050474606449(17)210810
• Combination Product (Y/N): Y
• Initial Reporter State: NY
• 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: health professional,user faci
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/09/2020
• 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: 08/10/2021
• Device Model Number: ZXT300
• Device Catalogue Number: ZXT300U230
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/23/2019
• Was the Report Sent to FDA?: No
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 09/23/2019
• Supplement Date Received by Manufacturer: 10/29/2019; 10/25/2020
• Initial Report FDA Received Date: 10/16/2019
• Supplement Report FDA Received Date: 11/18/2019; 11/10/2020
• 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: 58 YR
• Date Report Sent to FDA: 01/01/2005