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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 Difficult or Delayed Positioning (1157); Positioning Failure (1158); Use of Device Problem (1670)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 10/10/2017
Event Type  malfunction  
Manufacturer Narrative
Additional information: during follow up, it was reported that the issue was likely due to use error. Device available for evaluation; returned to manufacturer on 12/28/2017. Device evaluation: the cartridge was observed under microscope 10x magnification and the cartridge was observed broken in the cartridge tip with a protruded part. Scarce amounts of viscoelastic residues were observed in the cartridge tube. The condition of the cartridge tip appears to be caused by the force of the handpiece push rod since a scarce amount of viscoelastic was used. The complaint was verified; however, due to the condition of the lens, the complaint could be related to the handling process and not the manufacturing process. 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 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 abbott medical optics has been submitted.
 
Manufacturer Narrative
If implanted, give date: not applicable, as the device was not implantable. If explanted, give date: not applicable, as the device was not implantable. An attempt has been made to obtain missing information; however, to date, no response has been received. All pertinent information available to abbott medical optics has been submitted.
 
Event Description
It was reported that a loading tech, who was not 100 percent proficient at loading, folded and inserted an intraocular lens into a 1mtec30 cartridge and advanced it with a forcep, but not far enough. As a result, the plunger came under the lens and still moved it forward, but the lens was only partially expressed out. The cartridge was damaged. The lens was not inserted into the operative eye because of this event, which happened during handling, but prior to insertion. Reportedly, another lens was loaded and all went well with the patient. No additional information was provided.
 
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Brand NamePLATINUM 1 SERIES
Type of DeviceSURGICAL ADJUNCTS
Manufacturer (Section D)
ABBOTT MEDICAL OPTICS
santa ana CA 92705
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 Key7001515
MDR Text Key190047137
Report Number2648035-2017-02010
Device Sequence Number1
Product Code KYB
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K081545
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
Type of Report Initial,Followup
Report Date 02/07/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received11/03/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date01/10/2018
Device Model Number1MTEC30
Device Catalogue Number1MTEC30
Device Lot NumberCC00065
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/28/2017
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/11/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured01/10/2017
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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