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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 Bent
Event Type  Injury  
Manufacturer Narrative

Implant and explant dates: if implanted or explanted, give date: not applicable, as the product is not implantable. All pertinent information available to abbott medical optics has been submitted.

 
Event Description

It was reported that the tip of a 1mtec30 cartridge bent 90 degrees, which caused the zxr00 24. 0 diopter intraocular lens (iol) inside to rip on the inserter. There was an incision enlargement made. The replacement lens was the same model and diopter. No additional information was provided.

 
Manufacturer Narrative

Device evaluation: the product testing could not be performed as the product was not returned. The reported complaint cannot be confirmed. Manufacturing record review: the manufacturing process record was evaluated and no deviation was found during process related to the complaint issue reported. There was no discrepancy found during the mrr (manufacturing record review). The product was manufactured and released according to the specifications. A search revealed that no other complaints were received from this production order. Labeling review: the directions for use (dfu) was reviewed. The dfu adequately provides instructions and precautions for the proper use and handling of the product. Conclusion: based on the investigation results there is no indication of a product quality deficiency. All pertinent information available to johnson & johnson surgical vision, inc. Has been submitted.

 
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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 Key7147015
Report Number2648035-2017-02362
Device Sequence Number1
Product CodeKYB
Report Source Manufacturer
Source Type HEALTH PROFESSIONAL,USER FACI
Reporter Occupation
Type of Report Initial
Report Date 03/09/2018
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received12/26/2017
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator
Device EXPIRATION Date04/07/2018
Device MODEL Number1MTEC30
Device Catalogue Number1MTEC30
Device LOT NumberCC04214
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 Received02/26/2018
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured04/07/2017
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient TREATMENT DATA
Date Received: 12/26/2017 Patient Sequence Number: 1
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