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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 Crack; Difficult or Delayed Positioning; Device Operates Differently Than Expected
Event Date 01/17/2017
Event Type  Malfunction  
Manufacturer Narrative

If implanted, give date: not applicable as this is not an implantable device. If explanted, give date: not applicable as this is not an implantable device. Device evaluation: the cartridge was returned at the manufacturing site for evaluation. Visual inspection at 10x microscope magnification showed scarce residue of viscoelastic ovd (ophthalmic viscosurgical device) inside the cartridge tube, indicating that the device was handled and prepared for surgical use. An intraocular lens (iol) was observed stuck in the cartridge. The cartridge was observed deformed and cracked. The customer's reported complaint was verified. Manufacturing records review: the manufacturing records for the cartridge were reviewed. During manufacturing the operators inspect the neck, tube and tip areas for cracks. No cracking or stress marks are allowed. They also check the tip for any melting, roughness, dent, bent tip or smash condition. The product was manufactured and released according to specification. Labeling review: the directions for use (dfu) were reviewed. The directions for use (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 was verified. All pertinent information available to abbott medical optics has been submitted.

 
Event Description

It was reported that an intraocular lens (iol) got stuck in the cartridge and started coming out of the side of the cartridge when being advanced. Reportedly, the lens did not touch the patient's eye. Another lens, same model and diopter, was implanted. No incision enlargement, no suture used and no patient injury was reported. Additional information was received and it was learnt that the no damage was noticed on the cartridge before loading the lens. The tip of the cartridge was damaged after the lens was advanced and started to come out of the side of the cartridge tip. No further information was provided.

 
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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 Key6603278
Report Number2648035-2017-00966
Device Sequence Number1
Product CodeKYB
Report Source Manufacturer
Source Type DISTRIBUTOR,HEALTH PROFESSION
Reporter Occupation
Type of Report Initial
Report Date 05/31/2017
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received05/31/2017
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator
Device EXPIRATION Date10/31/2019
Device MODEL Number1MTEC30
Device Catalogue Number1MTEC30
Device LOT NumberCB41388
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer05/19/2017
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/05/2017
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured10/31/2016
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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