• 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 1-PIECE MONOFOCAL 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 1-PIECE MONOFOCAL IOLS Back to Search Results
Model Number ZCB00
Device Problem Break
Event Date 06/05/2019
Event Type  Injury  
Manufacturer Narrative

Date of event: unknown, information not provided. If explanted, give date: not applicable as lens was removed/replaced in the initial surgery. (b)(4). Device evaluation: product testing could not be performed as the product was not returned. The consumer¿s reported event could not be verified. Manufacturing record review: the manufacturing records for the product were reviewed. The product was manufactured and released according to specifications. A search revealed that no additional complaint was received for this production order. Conclusion: based on the investigation, no product deficiency was identified. All pertinent information available to johnson & johnson surgical vision, inc. Has been submitted.

 
Event Description

It was reported that the haptics of a zcb00 20. 5 diopter lens were stuck to each other. The lens was reported as explanted. Follow-up information was received which clarified that this not an explant in a secondary procedure, but there was patient contact as the iol was inserted and removed within the same procedure. The customer further explained that the iol had a broken haptic and not that the haptics were stuck to each other as initially reported. The lens was removed and replaced with the same model iol. An incision enlargement and sutures were required. The complaint lens was discarded by customer. Additionally, the customer explained that they began using bss (balanced salt solution) to prepare the lens, and they haven't had any problems since then. No further information was provided.

 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameTECNIS 1-PIECE
Type of DeviceMONOFOCAL IOLS
Manufacturer (Section D)
JOHNSON & JOHNSON SURGICAL VISION, INC.
1700 e st andrew place
santa ana CA 92705
Manufacturer (Section G)
JOHNSON & JOHNSON SURGICAL VISION, INC.
road 402 north, km 4.2
anasco industrial park
anasco PR 00610
Manufacturer Contact
somyata nagpal
1700 east st. andrew place
santa ana , CA 92705
7142478200
MDR Report Key8849209
Report Number2648035-2019-00829
Device Sequence Number1
Product CodeHQL
Report Source Manufacturer
Source Type HEALTH PROFESSIONAL,USER FACI
Reporter Occupation
Type of Report Initial
Report Date 01/01/2005,07/31/2019
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received07/31/2019
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberZCB00
Device Catalogue NumberZCB0000205
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA01/01/2005
Event Location No Information
Date Report TO Manufacturer01/10/2005
Date Manufacturer Received06/19/2019
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured11/07/2017
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient TREATMENT DATA
Date Received: 07/31/2019 Patient Sequence Number: 1
-
-