• 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 ITEC PRELOADED 1-PIECE IOL; 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 ITEC PRELOADED 1-PIECE IOL; MONOFOCAL IOLS Back to Search Results
Model Number PCB00
Device Problem Failure to Unfold or Unwrap (1669)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 07/14/2020
Event Type  malfunction  
Manufacturer Narrative
Lens was not implanted lens was not implanted, therefor not explanted (b)(6).All pertinent information available to johnson and johnson surgical vision, inc.Has been submitted.
 
Event Description
It was reported that the haptics wouldn't unfold.As per follow-up the lens was removed from the eye on the same day.No further interventions or patient issues were reported.No additional information was provided.
 
Manufacturer Narrative
Device evaluation: the preloaded unit was not returned for evaluation, only an empty product box was returned.Therefore, a failure analysis of the complaint device could not be performed.Manufacturing record evaluation: the manufacturing records for the intraocular lens were reviewed.The product was manufactured and released according to specification. a search revealed that one additional complaint for this order number have been received.But product deficiency not identified.Conclusion: as a result of the investigation, there is no indication of a product quality deficiency.All pertinent information available to johnson and johnson surgical vision, inc.Has been submitted.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
TECNIS ITEC PRELOADED 1-PIECE IOL
Type of Device
MONOFOCAL IOLS
Manufacturer (Section D)
JOHNSON & JOHNSON SURGICAL VISION, INC.
1700 e st andrew place
santa ana CA 92705
MDR Report Key10796634
MDR Text Key226164617
Report Number2648035-2020-00821
Device Sequence Number1
Product Code HQL
UDI-Device Identifier05050474558281
UDI-Public(01)05050474558281(17)211113
Combination Product (y/n)Y
PMA/PMN Number
P980040
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional,u
Type of Report Initial,Followup
Report Date 12/16/2020
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 Date11/13/2021
Device Model NumberPCB00
Device Catalogue NumberPCB0000210
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 10/09/2020
Initial Date FDA Received11/05/2020
Supplement Dates Manufacturer Received11/24/2020
Supplement Dates FDA Received12/16/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
-
-