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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: JOHNSON AND JOHNSON SURGICAL VISION, INC. PLATINUM 1 SERIES SURGICAL ADJUNCTS

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JOHNSON AND JOHNSON SURGICAL VISION, INC. PLATINUM 1 SERIES SURGICAL ADJUNCTS Back to Search Results
Model Number 1MTEC30
Device Problem Bent
Event Date 03/22/2018
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. All pertinent information available to johnson and johnson surgical vision, inc. Has been submitted.

 
Event Description

The surgeon loaded the intraocular lens into the cartridge and upon inserting it through the incision, he noticed the haptic was going into the eye at a weird angle. He tried dialing it back to see if it was loaded improperly when he then noticed the cartridge tip was bent at an angle. The lens was not fully discharged into the eye, just the beginning of the haptic. The second lens loaded and was implanted with no issues. The backup lens was the zcb00 22. 0d. The patient did not require additional medical/surgical intervention and left the hospital in good condition. No additional information was provided to johnson and johnson surgical vision, inc.

 
Manufacturer Narrative

Device evaluation: the cartridge was not retuned; however, photos were provided for evaluation. Based on the photos, the lens was observed in the loading zone area. Presence of lubricant material was observed on the loading and cartridge tube area. No damage was also observed to the cartridge tip. The condition of the cartridge is consistent with a product that was handled and prepared for surgical use. The complaint issue reported as tip deformed was not verified. Manufacturing records review: the manufacturing records for the product were reviewed. The product was manufactured and released according to specifications. A search revealed that no additional complaints for this order number have been received. Labeling review: the directions for use (dfu) were reviewed. The dfu provide the customer with proper usage instructions and guidelines. 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.

 
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Brand NamePLATINUM 1 SERIES
Type of DeviceSURGICAL ADJUNCTS
Manufacturer (Section D)
JOHNSON AND JOHNSON SURGICAL VISION, INC.
santa ana CA
Manufacturer (Section G)
JOHNSON AND 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 Key7449855
Report Number2648035-2018-00583
Device Sequence Number1
Product CodeKYB
Report Source Manufacturer
Source Type FOREIGN,HEALTH PROFESSIONAL,U
Reporter Occupation
Type of Report Initial
Report Date 06/07/2018
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received04/22/2018
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator
Device EXPIRATION Date08/23/2018
Device MODEL Number1MTEC30
Device Catalogue Number1MTEC30
Device LOT NumberCC10467
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/14/2018
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured08/23/2017
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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