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

Model Number	ZXT150
Medical Device Problem Code	Unintended Movement (3026)
Health Effect - Clinical Codes	Visual Disturbances (2140); No Consequences Or Impact To Patient (2199); No Code Available (3191)
Date of Event	12/24/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional information: date of birth/age: unknown was information was not provided.Gender/sex: unknown, information not provided.If explanted; give date: not applicable as the iol remains implanted in the patient's ocular dexter (right eye).It was indicated that the iol is not being returned for evaluation as it remains implanted in the ocular dexter (right eye) therefore, a failure analysis of the complaint device cannot be completed.A review of the device/lot history record and historical data analysis for this device will be performed.Upon completion of the review, if there is any further relevant information a supplemental medwatch report will be filed.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Event or Problem Description
It was reported a model zxt150 19.5 diopter intraocular lens (iol) was implanted in the patient¿s ocular dexter (right eye) on (b)(6) 2019, and was placed at 160 axis.Pre-operative best corrected visual acuity (bcva) was 20/40.On (b)(6) 2019 the clinical site reported the lens was at 150 axis, and bcva was 20/20.It was reported no intervention is planned.No additional information was provided to johnson & johnson surgical vision.
Additional Manufacturer Narrative
Additional information was received, and the following fields were updated accordingly.Section b-05 - describe event or problem: it was reported the patient came in for their one (01) month study visit on (b)(6) 2020; right eye ucdva was 20/20 and bcdva was 20/20.The following complaints were reported when driving at sun-up: moderately bothered by starbursts, moderately bothered by sensitivity to light, moderately bothered by glare related to scattered light.No intervention is planned at this time.Od preoperative visual acuity was reported as: ucdva 20/150 and bcva 20/40.No additional information was provided.Section h-6: patient code 3191 ¿ glare.Section h-6: patient code 3191 ¿ photophobia.Device evaluation: product testing could not be performed because the product was not returned as the lens remains implanted in the patient¿s ocular dexter (right eye).A product quality deficiency could not be confirmed.The reported issue was not verified.Manufacturing records review: the manufacturing records for the product were reviewed, the product was manufactured and released according to specification.Historical data analysis: a search revealed that no similar complaints for this production order number have been received.Conclusion: as a result, of the investigation there is no indication of a product malfunction or product quality deficiency.The reported issue was not verified.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Additional Manufacturer Narrative
Corrected data: the initial reporter information was known at the time of submission of follow-up report #1, but inadvertently not included.Therefore, the following fields were updated accordingly: section e-1 title, first and last name: (b)(6) phone:(b)(6) email: unknown ¿ information not provided facility name: (b)(6).Country: us section e-2 health professional: yes section e-3 occupation: physician section e-4 initial reporter also sent report to fda: unk all pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.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: 9614461
• Report Number: 9614546-2020-00030
• Device Sequence Number: 11366794
• Product Code: POE
• UDI-Device Identifier: 05050474605190
• UDI-Public: (01)05050474605190(17)220831
• Combination Product (Y/N): Y
• Initial Reporter State: MD
• Initial Reporter Country: US
• PMA/510(K) Number: P980040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,study
• 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?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 08/31/2022
• Device Model Number: ZXT150
• Device Catalogue Number: ZXT150U195
• 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: 12/24/2019
• Supplement Date Received by Manufacturer: 05/26/2020; 07/10/2020; 10/25/2020
• Initial Report FDA Received Date: 01/22/2020
• Supplement Report FDA Received Date: 06/04/2020; 07/13/2020; 11/04/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Date Report Sent to FDA: 01/01/2005