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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 Problems Failure to Eject ; Physical Resistance / Sticking
Event Date 06/18/2019
Event Type  Malfunction  
Manufacturer Narrative

Age/date of birth: unknown/ not provided. Sex/gender: unknown/ not provided. If implanted, if explanted, give date: not applicable, as cartridge is not an implantable device. Device evaluation: the product was discarded. As the product does not return for the evaluation, the complaint cannot be confirmed and either a product deficiency can be confirmed. Manufacturing record review: the manufacturing process record was evaluated and revealed that the product was manufactured and released according to specifications. A search revealed that no other complaints were received from this production order. Conclusion: 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.

 
Event Description

It was reported that a 1mtec30 cartridge was used with a zxt225 model lens, but the lens got stuck in cartridge and was partially delivered into the eye. Customer tried to reload the lens but it would not unfold. There was no incision enlargement, no vitrectomy and no sutures required. The patient has recovered. No other information was provided.

 
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Brand NamePLATINUM 1 SERIES
Type of DeviceSURGICAL ADJUNCTS
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 Key8829526
Report Number2648035-2019-00771
Device Sequence Number1
Product CodeKYB
Report Source Manufacturer
Source Type DISTRIBUTOR,HEALTH PROFESSION
Reporter Occupation
Type of Report Initial
Report Date 01/01/2005,07/25/2019
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received07/25/2019
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date10/25/2019
Device MODEL Number1MTEC30
Device Catalogue Number1MTEC30
Device LOT NumberCD11242
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 Received06/27/2019
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured10/25/2018
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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