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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 Device Contamination with Chemical or Other Material
Event Type  Malfunction  
Manufacturer Narrative

Date of event: unknown, not provided, but the best estimate date is during 2018. Lot #: unknown, as the lot number of the device was not provided. Expiration date: unknown, as the lot number of the device was not provided. Udi#: unknown, as the product 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. (b)(6). Device manufacture date: unknown, as the lot number of the device was not provided. All pertinent information available to johnson & johnson surgical vision, inc. Has been submitted.

 
Event Description

Customer reported that foreign material came out with the lens when used with non j&j vision viscoelastic. The physician was questioning the compatibility between the 1mtec30 cartridge and viscoelastic. The foreign material was removed by irrigation/aspiration (i/a) and the surgery was completed with no further issue. There was no patient injury. No additional information provided.

 
Manufacturer Narrative

Device available for evaluation? yes. Returned to manufacturer on: 5/7/2018. Device returned to manufacturer? yes. Device evaluation: two (2) empty 1mtec30 was returned with a digital video disc (dvd). Visual inspection using microscope magnification was performed to the sample returned: the two (2) cartridges were inspected under microscope magnification and viscoelastic residues were observed in the cartridge tube. Cartridge damages were not observed in any of the samples received. Dvd was evaluated by the subject matter expert (sme) and the viscous material was observed in the cartridges used in the procedures recorded. Therefore, the complaint was verified. The condition of the sample returned is consistent with a product that was previously handled and it could not be determined if the reported issue is related to the manufacturing process. Based in the analysis, there is no indications of product quality deficiency. Eag evaluation: the samples was sent to evans analytical group (eag) laboratories for further analysis. Fourier transform infrared (ftir) analysis shows that debris located inside both cartridges is consistent with a mixture, possibly containing some or all of the following: an acrylic species, a vinyl polymer similar to polyvinyl pyrrolidone, and sodium hyaluronate, which is the active component in the ophthalmic viscosurgical device (ovd) used in the cataract procedure and is a component in the lubricious coating used in the 1mtec30 cartridge. Each sample cartridge was cut open with a steel surgical blade to expose the interior. Identical debris was located inside each cartridge, consisting of a thin film and a solid piece that appeared to conform to the circular shape of the cartridge tip. Based in the eag lab analysis and the sme evaluation, the manufacturing process for 1mtec30 in various steps could have exposed to the types of material presents in the sample, however, throughout the manufacturing processes there are various cleaning operations and 100% visual inspection utilizing a microscope magnification steps that would have identified and discarded a lens with a similar particulate for any type of debris. Manufacturing record review: the manufacturing record cannot be reviewed since lot number is unknown. Labeling review: the dfu was reviewed. The dfu adequately provides instructions and precautions for the proper use and handling of the product. Conclusion: based on the investigation results there is no indication of a product quality deficiency. 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
Manufacturer (Section G)
JOHNSON & JOHNSON SURGICAL VISION, INC.
road 402 north, km 4.2
anasco industrial park, pob 14
anasco PR 00610
Manufacturer Contact
pamela mcclain
1700 east st. andrew place
santa ana , CA 92705
7142478243
MDR Report Key7481781
Report Number2648035-2018-00642
Device Sequence Number1
Product CodeKYB
Report Source Manufacturer
Source Type FOREIGN,HEALTH PROFESSIONAL,U
Reporter Occupation
Type of Report Initial,Followup
Report Date 07/03/2018
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received05/02/2018
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator
Device MODEL Number1MTEC30
Device Catalogue Number1MTEC30
Device LOT NumberUNKNOWN
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer05/07/2018
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/06/2018
Was Device Evaluated By Manufacturer? Yes
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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