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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 Problem Delivery System Failure (2905)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 05/11/2016
Event Type  malfunction  
Manufacturer Narrative
All pertinent information available to abbott medical optics has been submitted.
 
Event Description
The customer indicated the cartridge was defective as the intraocular lens (iol) was stuck in the delivery device.The inserter plunger went out the back of the cartridge instead of pushing lens out the end.The lens was removed from the eye and replaced with the same model during the same procedure.There was no incision enlargement, no sutures, no patient injury.No additional information was provided to abbott medical optics.
 
Manufacturer Narrative
Device evaluation: evidence of viscoelastic ovd (ophthalmic viscosurgical device) residues was detected inside the cartridge tube, indicating the device was handled and prepared for surgical use.Visual inspection at 10x microscope magnification was performed.A cartridge crack was observed at the cartridge tube/tip that could be related to the hand piece pushrod.The lens was not in the cartridge.The reported device problem codes of iol partially delivered, override, stuck in cartridge, could not be verified; however, a cartridge crack was observed on the returned cartridge.Manufacturing records review: the manufacturing records for the product were reviewed.The product was manufactured and released according to specifications.Labeling review: the directions for use (dfu) were reviewed.The dfu adequately provide instructions and precautions along with warnings for the proper use and handling of the device.Conclusion: as a result of the investigation, there is no indication of a product quality deficiency.All pertinent information available to abbott medical optics has been submitted.
 
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Brand Name
PLATINUM 1 SERIES
Type of Device
SURGICAL 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
pamela mcclain
1700 east st. andrew place
santa ana, CA 92705
7142478243
MDR Report Key6004636
MDR Text Key56941142
Report Number2648035-2016-01560
Device Sequence Number1
Product Code KYB
UDI-Device Identifier05050474540323
UDI-Public(01)05050474540323(17)170112(10)CB22327
Combination Product (y/n)N
PMA/PMN Number
K081545
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor,health profession
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 11/15/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Physician
Device Expiration Date01/12/2017
Device Model Number1MTEC30
Device Catalogue Number1MTEC30
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 09/13/2016
Initial Date FDA Received10/06/2016
Supplement Dates Manufacturer ReceivedNot provided
Supplement Dates FDA Received11/15/2016
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured01/12/2016
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Treatment
ZCB00 IOL, SERIAL NUMBER (B)(4).
Patient Age78 YR
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