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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 Failure to Eject
Event Date 04/29/2019
Event Type  Malfunction  
Manufacturer Narrative

Lot number: unknown/not provided. Expiration date: unknown as product lot number was not provided. Udi #: a complete udi # is unknown, as lot number of the device was not provided. If implanted; give date: n/a (not applicable). The cartridge is not an implantable device. If explanted; give date: n/a (not applicable). The cartridge is not an implantable device. Device manufacture date: unknown, as device lot number was not provided. Device evaluation: the product has not been received at the investigation site. Therefore, a product investigation could not be performed and the customer's reported event could not be confirmed. Manufacturing record review: an evaluation of the manufacturing records and/or complaint occurrence of the production order are not possible since product identifiers are not available. As the lot number is unknown for this event, it was not possible to perform a complaint history/trending review. Based on the information provided, 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 a zcb00 intraocular lens (iol) got stuck in the cartridge. It was learnt that the iol was partially inserted into the eye, aside from being stuck in cartridge. Therefore, the lens could not be fully delivered into the patient's eye. There was no adverse event, nor any patient post-op injury. No other information can be 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 Key9112741
Report Number2648035-2019-01034
Device Sequence Number1
Product CodeKYB
Report Source Manufacturer
Source Type HEALTH PROFESSIONAL,USER FACI
Reporter Occupation
Type of Report Initial
Report Date 01/01/2005,09/24/2019
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received09/24/2019
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? 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 Received08/26/2019
Is this a Reprocessed and Reused Single-Use Device? No

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