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U.S. Department of Health and Human Services

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

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JOHNSON & JOHNSON SURGICAL VISION, INC. TECNIS SYMFONY; MULTIFOCAL IOLS Back to Search Results
Model Number ZXR00
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Visual Disturbances (2140); Halo (2227); No Code Available (3191)
Event Type  Injury  
Manufacturer Narrative
Date of event: unknown, not provided.Best estimate of date of event is between (b)(6) 2018 and (b)(6) 2019.(b)(4).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.
 
Event Description
It was reported that a zxr00 intraocular lens (iol) was implanted in 2018.The patient developed complaint of rings, inability to drive at night.Various glasses/contact lenses tried to resolve the issue but without success.The zxroo lens was explanted and was replaced with a monofocal lens.This report captures the event for the left eye.A separate report is being submitted for the right eye.Follow-up noted that no product is coming back for this event.The contact person doesn't know date of when the visual issues 1st occurred.However, the contact person confirmed that there was no incision enlargement, no vitrectomy and no sutures performed.Patient was well post-op.No other information was received.
 
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.
 
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Brand Name
TECNIS SYMFONY
Type of Device
MULTIFOCAL IOLS
Manufacturer (Section D)
JOHNSON & JOHNSON SURGICAL VISION, INC.
1700 e st andrew place
santa ana CA 92705
MDR Report Key8952830
MDR Text Key160895788
Report Number9614546-2019-00800
Device Sequence Number1
Product Code MFK
UDI-Device Identifier05050474579231
UDI-Public(01)05050474579231(17)211006
Combination Product (y/n)Y
PMA/PMN Number
P980040
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Type of Report Initial,Followup
Report Date 01/01/2005,11/11/2020
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
Device Operator Health Professional
Device Expiration Date10/06/2021
Device Model NumberZXR00
Device Catalogue NumberZXR00U0270
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Date Report Sent to FDA01/01/2005
Date Report to Manufacturer01/10/2005
Initial Date Manufacturer Received 08/07/2019
Initial Date FDA Received08/30/2019
Supplement Dates Manufacturer Received10/25/2020
Supplement Dates FDA Received11/11/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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