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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: JOHNSON & JOHNSON SURGICAL VISION, INC. PLATINUM 1 SERIES; SURGICAL ADJUNCTS

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JOHNSON & JOHNSON SURGICAL VISION, INC. PLATINUM 1 SERIES; SURGICAL ADJUNCTS Back to Search Results
Model Number 1MTEC30
Device Problem Deformation Due to Compressive Stress (2889)
Patient Problem No Patient Involvement (2645)
Event Date 04/04/2018
Event Type  malfunction  
Manufacturer Narrative
If implanted, give date: not applicable, as the product is not implantable.If explanted, give date: not applicable, as the product is not implantable.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
 
Event Description
It was reported that a bump was noticed at the end of a 1mtec30 cartridge during handling and prior to insertion with no patient contact.No additional information was provided.
 
Manufacturer Narrative
Device available for evaluation, returned to manufacturer on: 04/27/2018.Device evaluation: the product was returned to the manufacturing site for evaluation.Visual inspection showed the cartridge tip was observed crack and damaged.The complaint issue reported was verified.The condition in which the sample was returned is consistent with a product that was handled for surgical process.Based on the analysis there is no indication of product quality deficiency.Manufacturing records review: the manufacturing records for the intraocular lens were reviewed.The product was manufactured and released according to specification.Labeling review: the directions for use (dfu) was reviewed.The dfu adequately provides instructions and precautions along with warnings for the proper use and handling of the device.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.
 
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Brand Name
PLATINUM 1 SERIES
Type of Device
SURGICAL ADJUNCTS
Manufacturer (Section D)
JOHNSON & JOHNSON SURGICAL VISION, INC.
santa ana CA
Manufacturer (Section G)
JOHNSON & JOHNSON SURGICAL VISION, INC.
road 402 north, km 4.2
anasco industrial park, pob 14
anasco PR 00610
Manufacturer Contact
pam mcclain
1700 east st. andrew place
santa ana, CA 92705
7142478243
MDR Report Key7482162
MDR Text Key107195091
Report Number2648035-2018-00643
Device Sequence Number1
Product Code KYB
UDI-Device Identifier05050474540323
UDI-Public(01)05050474540323(17)190118(10)CD00737
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
P980040
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional,user faci
Reporter Occupation Other
Type of Report Initial,Followup
Report Date 05/23/2018
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 Physician
Device Expiration Date01/18/2019
Device Model Number1MTEC30
Device Catalogue Number1MTEC30
Device Lot NumberCD00737
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/27/2018
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 04/04/2018
Initial Date FDA Received05/02/2018
Supplement Dates Manufacturer Received05/22/2018
Supplement Dates FDA Received05/23/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured01/18/2018
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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