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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: JOHNSON & JOHNSON SURGICAL VISION, INC. PLATINUM 1 SERIES UNFOLDER CARTRIDGE

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JOHNSON & JOHNSON SURGICAL VISION, INC. PLATINUM 1 SERIES UNFOLDER CARTRIDGE Back to Search Results
Model Number 1MTEC30
Device Problems Improper or Incorrect Procedure or Method; Failure to Eject
Event Date 04/17/2019
Event Type  Malfunction  
Manufacturer Narrative

Lot #: unknown, not provided. Expiration date: unknown, as the lot number was not provided. Unique identifier number, a complete udi# is unknown as the 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. Device manufacture date: unknown, as the lot number was not provided all pertinent information available to johnson & johnson surgical vision, inc. Has been submitted.

 
Event Description

It was reported that a zct150 intraocular lens (iol) was stuck in the cartridge and could not advance. Lens was in the incision and it did touch the eye. The lens was not implanted. No issue with procedure, no injury or surgical intervention required. Surgery was completed, another zct150 19. 5 diopter lens was implanted. No additional information provided.

 
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Brand NamePLATINUM 1 SERIES
Type of DeviceUNFOLDER CARTRIDGE
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.
van swietenlaan 5
groningen 9728 NX
NL  9728 NX
Manufacturer Contact
somyata nagpal
1700 east st. andrew place
santa ana , CA 92705
7142478200
MDR Report Key8725269
Report Number2648035-2019-00662
Device Sequence Number1
Product CodeKYB
Report Source Manufacturer
Source Type HEALTH PROFESSIONAL,USER FACI
Reporter Occupation
Type of Report Initial
Report Date 01/01/2005,07/30/2019
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received06/21/2019
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL Number1MTEC30
Device Catalogue Number1MTEC30
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No
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 Received07/01/2019
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

Patient TREATMENT DATA
Date Received: 06/21/2019 Patient Sequence Number: 1
Treatment
ZCT150 LENS, SN: (B)(4)
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