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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 Consequences Or Impact To Patient (2199)
Event Date 04/24/2019
Event Type  malfunction  
Manufacturer Narrative
If implanted, give date: not applicable as this is not an implantable device.   if explanted, give date: not applicable as this is not an implantable device.   concomitant medical products: platinum 1 inserter serial number unknown/not provided, zxr00 intraocular lens serial number (b)(4). Device evaluation: product testing could not be performed as the device was not returned. The complaint issue reported could not be verified. Manufacturing records review: the manufacturing records for the product were reviewed. The product was manufactured and released according to specification. A search on complaints was conducted and revealed no additional investigation request received for this production order number. Labeling review: the directions for use (dfu) were reviewed. The dfu adequately provides instructions and precautions along with warnings for the proper use and handling of the device. Conclusion: as a result of the investigation, there is no indication of a product quality deficiency. All pertinent information available to johnson and johnson surgical vision, inc. Has been submitted.
 
Event Description
It was reported that while implanting the lens the physician experienced an unusual resistance with the cartridge and injector. Once the lens was in implanted in the eye, the physician observed a small piece of plastic material remaining in the eye. It was removed without any impact to the patient. Reportedly the plastic foreign body was in the cartridge. The symfony iol appeared normal. No additional information received.
 
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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 Key8634839
MDR Text Key145905535
Report Number2648035-2019-00591
Device Sequence Number1
Product Code KYB
Combination Product (y/n)Y
Reporter Country CodeCA
PMA/PMN Number
K081545
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial,Followup
Report Date 01/01/2005,11/12/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received05/23/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date04/19/2019
Device Model Number1MTEC30
Device Catalogue Number1MTEC30
Device Lot NumberCD04450
Was Device Available for Evaluation? No
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? Device Not Returned to Manufacturer
Date Device Manufactured04/19/2018
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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