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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 Contamination (1120)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Type  malfunction  
Manufacturer Narrative
Date of event: exact date unknown, not provided. Best estimate (b)(6) 2019. If implanted; if explanted; give date: n/a (not applicable). The cartridge is not an implantable device. All pertinent information available to johnson & johnson surgical vision, inc. Has been submitted.
 
Event Description
It was reported that the doctor is seeing an increase in plaques coming from the cartridges at time of lens injection. Maybe 50% of recent cases. The doctor shared two (2) specific case images that occurred recently with a flake of material that goes in from the injector with the lens. It was also stated that the debris is easy to take out by irrigation and aspiration (ia). Follow-up noted that they have had this issue before (approx. 2 years ago) and it went away from some time and manifested again around the beginning of summer, but no exact dates or other specific information provided. It was learned that all patients had no adverse events and one of the doctor¿s colleagues did leave it in the eye and the patient was fine. No other information was provided. 2 mdr reports are required, one for each case reported. This mdr is to capture case#2. Another mdr is submitted to capture case #1.
 
Manufacturer Narrative
Device available for evaluation; returned to manufacturer on: 10/29/2019. Device evaluation: the sample was evaluated by a principal engineer and no damages or flaws were observed. The complaint reported was not verified and no product deficiency was identified. In addition, photos were provided and were reviewed. The photo shows as per customer information two cases with the flake (debris/particle) sitting on posterior aspect of the lens. However, the origin or the source of the material is unknown. Based on the sample evaluation that was returned, no damages were identified. Manufacturing record review: the manufacturing process record was evaluated and revealed that the product was manufactured and released according to specifications. A search revealed that no additional investigations were received related to this production order. Conclusion: as a result of the investigation there is no indication of a product quality deficiency and the reported issue could not be verified. All pertinent information available to johnson & johnson surgical vision, inc. Has been submitted.
 
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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 Key9188908
MDR Text Key166321266
Report Number2648035-2019-01095
Device Sequence Number1
Product Code KYB
Combination Product (y/n)Y
Reporter Country CodeUS
PMA/PMN Number
K081545
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional,user faci
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 01/01/2005,11/09/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received10/14/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date06/26/2020
Device Model Number1MTEC30
Device Catalogue Number1MTEC30
Device Lot NumberCE06376
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/29/2019
Is the Reporter a Health Professional? Yes
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
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured06/26/2019
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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