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U.S. Department of Health and Human Services

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

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JOHNSON & JOHNSON SURGICAL VISION, INC. TECNIS; TORIC IOLS Back to Search Results
Model Number ZCT150
Device Problems Manufacturing, Packaging or Shipping Problem (2975); Scratched Material (3020)
Patient Problem No Patient Involvement (2645)
Event Date 06/12/2019
Event Type  malfunction  
Manufacturer Narrative
Age/date of birth: unknown, information not provided.Gender/sex: unknown, information not provided.If implanted, if explanted, give date: not applicable, as lens was not implanted.(b)(6).Device evaluation: product testing could not be performed because the product was not returned.Manufacturing records review: the manufacturing records for the product were reviewed.The product was manufactured and released according to specification.A search revealed that no similar complaints were received for this production order number.Conclusion: as a result of the investigation, there is no indication of a product quality deficiency.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
 
Event Description
It was reported that an intraocular lens(iol) had a packaging issue.There was no patient contact with the lens.Additional information was provided stating that upon opening the package lens was not positioned properly in the container.Lens found to be scratched as the top of the container rubbed against it.No other information provided.
 
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
Type of Device
TORIC IOLS
Manufacturer (Section D)
JOHNSON & JOHNSON SURGICAL VISION, INC.
1700 e st andrew place
santa ana CA 92705
MDR Report Key8787309
MDR Text Key151285106
Report Number9614546-2019-00610
Device Sequence Number1
Product Code HQL
UDI-Device Identifier05050474538207
UDI-Public(01)05050474538207(17)210422
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 01/01/2005,11/12/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date04/22/2021
Device Model NumberZCT150
Device Catalogue NumberZCT1500220
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 06/17/2019
Initial Date FDA Received07/12/2019
Supplement Dates Manufacturer Received10/25/2020
Supplement Dates FDA Received11/13/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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