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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 06/24/2019
Event Type  Malfunction  
Manufacturer Narrative

Age/date of birth: unknown/ not provided. Sex/gender: unknown/ not provided. Lot #: unknown,not provided. Expiration date: unknown as lot number was not provided. Unique identifier number (udi#): a complete udi# is unknown as the lot# was not provided. If implanted, if explanted, give date: not applicable, cartridge is not an implantable device. Expiration date: unknown as lot number was not provided. Device evaluation: it was confirmed that only the suspect lens was returned. Since cartridge is not available, the complaint issue reported could not be verified. Product deficiency could not be determined. Manufacturing record review could not be performed since lot number is unknown. The complaint occurrences per lot/batch also could not be performed since lot number is unknown. As a result of the investigation there is no indication of a product quality deficiency and the reported issue could not be verified. Attempts have been made to obtain missing information; however, no definitive response has been received. All pertinent information available to johnson & johnson surgical vision, inc. Has been submitted.

 
Event Description

It was reported that during insertion of a model zlb00 intraocular lens (iol), the lens got stuck in the 1mtec30 cartridge. It was stated that there was patient contact. Through follow-up it was learnt that the lens was partially delivered into the eye, and then it got stuck in the cartridge. There was no incision enlargement, vitrectomy, or sutures required. Only the iol involved in the event is being returned, not the cartridge. The patient is reported to be fine, surgery went well post-op. 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 Key8829543
Report Number2648035-2019-00772
Device Sequence Number1
Product CodeKYB
Report Source Manufacturer
Source Type HEALTH PROFESSIONAL,USER FACI
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 MODEL Number1MTEC30
Device Catalogue Number1MTEC30
Device LOT NumberUNKNOWN
Was Device Available For Evaluation? No
Is The Reporter A Health Professional?
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
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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