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

Model Number	ZXT150
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Codes	Visual Impairment (2138); No Code Available (3191)
Date of Event	05/21/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
If explanted, give date: to date the lens remains implanted but an explant is planned (date unknown).(b)(4).An attempt has 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 during a post-operative examination, there was a mechanical complication with an intraocular lens (iol) implanted into the patient left eye.The patient's pre- and post-op visual acuity was reported as 20/25 for the left eye.An explant of the intraocular lens is planned.No additional information was provided.
Additional Manufacturer Narrative
Additional information received reported the intraocular lens (iol) was explanted as planned because the symfony toric lens flipped axis and induced cylinder that the patient did not tolerate.The patient experienced poor visual acuity.An incision enlargement was required to remove the initial iol.There were no other medical or surgical intervention planned or performed and no patient injury.The explanted iol was replaced with another lens of a different model and higher diopter.The patient was doing well post-operatively.Visual acuity: os (surgical eye) 20/25, j1.As a result of the additional information, the following field have been updated: patient code 3191: explant.Patient code 3191: incision enlargement.Device evaluation: product testing could not be performed because the product was not returned.The complaint cannot be confirmed.Manufacturing records 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 number.Conclusion: as a result of the investigation there is no indication of a quality product 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
Correction: in review of the supplemental mdr, it was determine that method code 3331 was inadvertently not included in the report.As a result the following field has been updated: method code - 3331.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-(b)(4) 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: 8729917
• Report Number: 9614546-2019-00577
• Device Sequence Number: 2472238
• Product Code: POE
• UDI-Device Identifier: 05050474605039
• UDI-Public: (01)05050474605039(17)210711
• 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
• 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): 11/12/2020
• 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: 07/11/2021
• Device Model Number: ZXT150
• Device Catalogue Number: ZXT150U115
• 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: 05/27/2019
• Supplement Date Received by Manufacturer: 07/11/2019; 08/09/2019; 10/25/2020
• Initial Report FDA Received Date: 06/25/2019
• Supplement Report FDA Received Date: 08/05/2019; 08/09/2019; 11/13/2020
• 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: 65 YR
• Date Report Sent to FDA: 01/01/2005