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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 Material Split, Cut or Torn (4008)
Patient Problem No Code Available (3191)
Event Date 07/23/2018
Event Type  malfunction  
Manufacturer Narrative
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. (b)(4). All pertinent information available to johnson & johnson surgical vision, inc. Has been submitted.
 
Event Description
It was reported that 1mtec30 un-folder cartridge split open upon injecting the lens inside the patient's eye. As a result, the surgeon decided to abort the process and replace it with other lens. Furthermore, the customer confirmed that the split was at the cartridge tip per follow-up. It was noted also that incision has been enlarged prior to inserting the lens. However, there were no suture, no vitrectomy and no apparent patient injury reported at that time. No additional information provided.
 
Manufacturer Narrative
Device evaluation: the product was not returned to the manufacturing site. Therefore, product testing could not be performed and the customer¿s reported complaint could not be verified. Manufacturing records review: the manufacturing records for the product was reviewed. The product was manufactured and released according to specification. A search in the complaint system was performed on september 19, 2018 revealed an additional investigation request for this production order number with a reported device problem code of cartridge damaged. The investigation is closed, no product deficiency was determined. Labeling review: the directions for use (dfu) was reviewed. The dfu adequately provides instructions and precautions along with warnings for the proper use and handling of the device. 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.
santa ana CA 92705
MDR Report Key7837669
MDR Text Key119027683
Report Number2648035-2018-01199
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 company representative,health
Type of Report Initial,Followup,Followup
Report Date 01/01/2005,11/02/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received08/31/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date11/10/2018
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

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