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

Model Number	ZXT150
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Visual Disturbances (2140); Halo (2227); No Code Available (3191)
Date of Event	04/15/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Attempts have been made to obtain missing information; however, no definitive response has been received.All pertinent information available to johnson and johnson surgical vision, inc.Has been submitted.
Event or Problem Description
It was reported that a zxt150 intraocular lens (iol) was explanted from the patient¿s left eye due to calculation issues.The patient could not tolerate the glare and halos of the zxt150.It was learned that the patient had a conjunctival cyst and macular edema during his post op period which were treated.But on (b)(6) 2019 the patient complained that the glare and rings/halos around lights were becoming very bothersome.The pre-op uncorrected distance vision (ucdv) at 4 feet.Manifect refraction (mrx) -5.50 -0.75 x 175 add +2.50 best corrected distance vision (bcdv) 20/30+.Post op: ucdv 20/30+ mrx pl -.75 x 22 bcdv 20/15-1.At explant it was noted that during explant, there was no incision enlargement, no vitrectomy, however the doctor did put in one suture.The patient tolerated the procedure well, and was discharged in stable condition without incident.No other information was provided.
Additional Manufacturer Narrative
Device evaluation: product testing could not be performed because the product was not returned.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: 9513529
• Report Number: 9614546-2019-01127
• Device Sequence Number: 2703034
• Product Code: MFK
• UDI-Device Identifier: 05050474604995
• UDI-Public: (01)05050474604995(17)210710
• 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: health professional,user faci
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/05/2020
• 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: 07/10/2021
• Device Model Number: ZXT150
• Device Catalogue Number: ZXT150U095
• 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: 11/26/2019
• Supplement Date Received by Manufacturer: 01/14/2020; 10/25/2020
• Initial Report FDA Received Date: 12/23/2019
• Supplement Report FDA Received Date: 01/21/2020; 11/05/2020
• 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: 69 YR
• Date Report Sent to FDA: 01/01/2005