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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 Mechanical Problem; Failure to Eject
Event Date 12/05/2019
Event Type  Malfunction  
Manufacturer Narrative

Catalog #: a complete catalog # is unknown as lot number was not provided. Unique identifier (udi#): a complete udi# is unknown, as lot number was not provided. Expiration date: unknown, as lot number 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; therefore, not explanted. Title, last name: unknown, information not provided. Device manufacture date: unknown as lot number was not provided. Device evaluation: the complaint sample was not returned to the manufacturing site (the cartridge was discarded); therefore, product testing could not be performed, and the customer's reported complaint could not be verified. Manufacturing record evaluation: manufacturing record review cannot be performed since the lot number is unknown. A search of complaints related to lot number cannot be performed since the lot number is unknown. Conclusion: since no sample was returned and the lot number is unknown an investigation could not be performed, and no malfunction is confirmed. All pertinent information available to johnson & johnson surgical vision, inc. Has been submitted.

 
Event Description

It was reported by the customer that a zcb00 model intraocular lens (iol) was stuck in inserter and had plunger rod issue. Additional information was received stating that the lens was partially delivered into the patient's right eye, and was stuck in cartridge. No surgical interventions such as vitrectomy, incision enlargement or sutures were required. The replacement lens used is a zcb00 21. 0 diopter lens. The patient was doing great at the time of discharge. The device was noted to be discarded. No further 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 Key9667404
Report Number2648035-2020-00110
Device Sequence Number1
Product CodeKYB
Report Source Manufacturer
Source Type FOREIGN,HEALTH PROFESSIONAL,U
Reporter Occupation
Type of Report Initial
Report Date 01/01/2005,02/04/2020
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received02/04/2020
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 Received01/07/2020
Is this a Reprocessed and Reused Single-Use Device? No

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