• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

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

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

JOHNSON & JOHNSON SURGICAL VISION, INC. TECNIS; TORIC IOLS Back to Search Results
Model Number ZCT450
Device Problem Unintended Movement (3026)
Patient Problems Retinal Detachment (2047); Blurred Vision (2137); No Code Available (3191)
Event Type  Injury  
Manufacturer Narrative
Date of event: unknown, not provided, but the best estimate date is from (b)(6) 2019 to present.If explanted; give date: not applicable; lens remains implanted.(b)(4).Device evaluation: the product testing could not be performed as the product was not returned (the lens remains implanted).The reported complaint cannot be confirmed.Manufacturing records review: the manufacturing records for the product were reviewed and no deviation was found during processes related to the complaint issue reported.The product was manufactured and released according to specification.A search in the complaint system revealed that no other complaint has been received for this production order number.Conclusion: as a result of the investigation there is no indication of a product quality deficiency and the reported issue could not be verified.Note: the device was manufactured at the kulim site which has been closed.All pertinent information available to johnson and johnson surgical vision, inc.Has been submitted.
 
Event Description
A male patient reported that he was implanted with an intraocular lens (iol), model zct450 10.0 diopter in the right eye (od).One-day post-op, (b)(6) 2019, the lens had to be repositioned due to a 108-degree rotation.No other surgical interventions and no patient injury were reported when the lens was repositioned.The patient reports blurry vision sometimes with signs and television, and he has glare issue at night time when driving.It was noted that the symptoms are not debilitating, and he is able to perform his daily tasks/activities.The patient also reported that he had detached retina after the lens was repositioned.His doctor told him that it was due to patient¿s stretched/very tight retina.The patient was referred to a retina specialist who stitched his retina and gave him gas treatment to resolve the issue.The patient also reports bad astigmatism in both eyes (od: 4.25 and os: 3.0).The patient was given progressive readers to use for close range and when he is on computer.Prescription for od: sphere: +0.5, cylinder: -1.0, axis: 163 and magnification: 2.5.No additional information was provided.This report pertains to the patient's right eye (od).A separate report is being submitted for the patient's left eye (os).
 
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.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
TECNIS
Type of Device
TORIC IOLS
Manufacturer (Section D)
JOHNSON & JOHNSON SURGICAL VISION, INC.
1700 e st andrew place
santa ana CA 92705
MDR Report Key9684116
MDR Text Key178545261
Report Number2020664-2020-00010
Device Sequence Number1
Product Code HQL
UDI-Device Identifier05050474602786
UDI-Public(01)05050474602786(17)230530
Combination Product (y/n)Y
PMA/PMN Number
P980040
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer
Type of Report Initial,Followup
Report Date 01/01/2005,11/03/2020
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? Yes
Device Operator Health Professional
Device Expiration Date05/30/2023
Device Model NumberZCT450
Device Catalogue NumberZCT450U100
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 01/13/2020
Initial Date FDA Received02/07/2020
Supplement Dates Manufacturer Received10/25/2020
Supplement Dates FDA Received11/03/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
-
-