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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ABBOTT MEDICAL OPTICS PLATINUM 1 SERIES SURGICAL ADJUNCTS

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ABBOTT MEDICAL OPTICS PLATINUM 1 SERIES SURGICAL ADJUNCTS Back to Search Results
Model Number 1MTEC30
Device Problems Positioning Failure ; Device Operates Differently Than Expected
Event Date 01/24/2018
Event Type  Malfunction  
Manufacturer Narrative

This is not an implantable device. Device evaluation: the 1mtec30 cartridge 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 1mtec30 cartridge were reviewed. The product was manufactured and released according to specification. A search on complaints revealed that no similar complaints have been received for this production order number. 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 abbott medical optics has been submitted.

 
Event Description

It was reported that on (b)(6) 2018, while inserting tecnis monofocal intraocular lens (model zcb00 +20. 5 diopter) the unfolder cartridge (model 1mtec30) partially delivered the lens and the lens got stuck in cartridge. This lens was removed and reportedly doctor again tried to insert another tecnis monofocal intraocular lens (model zcb00 +20. 5 diopter) using another unfolder cartridge (model 1mtec30), however this lens too got partially delivered and then got stuck in cartridge. A third tecnis monofocal intraocular lens (model zcb00 +20. 5 diopter) was implanted without any issue. There was no patient injury reported. No further information provided. This report is for second attempt. A separate report is being submitted for first attempt.

 
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Brand NamePLATINUM 1 SERIES
Type of DeviceSURGICAL ADJUNCTS
Manufacturer (Section D)
ABBOTT MEDICAL OPTICS
santa ana CA
Manufacturer (Section G)
ABBOTT MEDICAL OPTICS INC.
road 402 north, km 4.2
anasco industrial park, pob 14
anasco PR 00610
Manufacturer Contact
pam mcclain
1700 east st. andrew place
santa ana , CA 92705
7142478243
MDR Report Key7298500
Report Number2648035-2018-00299
Device Sequence Number1
Product CodeKYB
Report Source Manufacturer
Source Type HEALTH PROFESSIONAL,USER FACI
Reporter Occupation
Type of Report Initial
Report Date 02/26/2018
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received02/26/2018
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator
Device EXPIRATION Date11/17/2018
Device MODEL Number1MTEC30
Device Catalogue Number1MTEC30
Device LOT NumberCC13690
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/30/2018
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured11/17/2017
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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