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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: JOHNSON & JOHNSON SURGICAL VISION PLATINUM 1 SERIES SURGICAL ADJUNCTS

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JOHNSON & JOHNSON SURGICAL VISION PLATINUM 1 SERIES SURGICAL ADJUNCTS Back to Search Results
Model Number 1MTEC30
Device Problems Break; Device Contamination with Chemical or Other Material
Event Date 08/06/2018
Event Type  Malfunction  
Manufacturer Narrative

If implanted, give date: not applicable, as the product was not implantable. If explanted, give date: not applicable, as the product was not implantable. It was indicated that the device is not returning for evaluation; therefore a failure analysis of the complaint device cannot be completed. A review of the device/lot history record, labeling, complaint trending, and risk documentation for this device will be performed. Upon completion of the review, if there is any further relevant information a supplemental medwatch will be filed. All pertinent information available to johnson & johnson surgical vision, inc. Has been submitted.

 
Event Description

The customer reported that during handling; prior to insertion of the intraocular lens (iol), they noted the cartridge was bad and had ripped the haptic of the lens. Further follow up was provided and confirmed that when the doctor was inserting the lens, a piece of the cartridge had broken and was in the eye. The piece was removed from the eye incision. No patient injury or complications happened as the problem was caught prior to the lens implant. The only intervention was to retrieve a new lens and cartridge, which was placed without complication. No additional information was provided.

 
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Brand NamePLATINUM 1 SERIES
Type of DeviceSURGICAL ADJUNCTS
Manufacturer (Section D)
JOHNSON & JOHNSON SURGICAL VISION
santa ana CA
Manufacturer (Section G)
JOHNSON & JOHNSON SURGICAL VISION
road 402 north, km 4.2
anasco industrial park
anasco PR 00610
Manufacturer Contact
pam mcclain
1700 east st. andrew place
santa ana , CA 92705
7142478243
MDR Report Key7887817
Report Number2648035-2018-01246
Device Sequence Number1
Product CodeKYB
Report Source Manufacturer
Source Type HEALTH PROFESSIONAL,USER FACI
Reporter Occupation
Type of Report Initial,Followup
Report Date 01/01/2005,12/05/2018
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received09/18/2018
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date04/13/2019
Device MODEL Number1MTEC30
Device Catalogue Number1MTEC30
Device LOT NumberCD04402
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer10/22/2018
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA01/01/2005
Event Location No Information
Date Report TO Manufacturer01/10/2005
Date Manufacturer Received11/07/2018
Is this a Reprocessed and Reused Single-Use Device? No

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