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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 (2017); Failure to Eject (4010)
Patient Problem No Known Impact Or Consequence To Patient (2692)
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.
 
Manufacturer Narrative
Device evaluation: the product is not available, the complaint issue reported could not be verified. Manufacturing records review: manufacturing record review could not be performed since lot number is unknown. Historical data analysis: the complaint occurrences per lot/batch could not be performed since lot number is unknown. Conclusion: as a result of the investigation there is no indication of a quality product deficiency and the reported issue could not be verified. Attempts have been made to obtain product and missing information; however, to date, no response has been received. All pertinent information available to johnson & johnson surgical vision, inc. Has been submitted.
 
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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
MDR Report Key8725269
MDR Text Key148941417
Report Number2648035-2019-00662
Device Sequence Number1
Product Code KYB
Combination Product (y/n)Y
PMA/PMN Number
K081545
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional,user faci
Type of Report Initial,Followup,Followup
Report Date 01/01/2005,11/11/2020
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
Device Model Number1MTEC30
Device Catalogue Number1MTEC30
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Date Report Sent to FDA01/01/2005
Event Location No Information
Date Report to Manufacturer01/10/2005
Date Manufacturer Received10/25/2020
Is This a Reprocessed and Reused Single-Use Device? No

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