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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STAAR SURGICAL COMPANY MICROSTAAR® INJECTOR INTRAOCULAR LENS GUIDE

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STAAR SURGICAL COMPANY MICROSTAAR® INJECTOR INTRAOCULAR LENS GUIDE Back to Search Results
Model Number MSI-TM
Device Problem Device Operates Differently Than Expected
Event Date 11/03/2016
Event Type  Injury  
Manufacturer Narrative

(b)(4).

 
Event Description

The reporter indicated the surgeon inserted an aq2010v silicone three piece lens, +19. 0 diopter, on (b)(6) 2016 and the lens was torn by the inserting device. The incision was enlarged to remove the lens. The backup lens was implanted and a suture was required to close the incision. Additional information has been requested but none has been forthcoming. If additional information is received, a supplemental medwatch report will be submitted.

 
Manufacturer Narrative

Device evaluation: visual inspection of the returned product found no visible damage to the injector. There was foreign material in the injector. The cartridge was returned with a damaged tip. The lens was returned and the lens optic was cut into two pieces, with a piece missing. The lens was returned dry. Lens work search: no similar complaints were reported for units within the same lot. Claim # (b)(4).

 
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Brand NameMICROSTAAR® INJECTOR
Type of DeviceINTRAOCULAR LENS GUIDE
Manufacturer (Section D)
STAAR SURGICAL COMPANY
1911 walker avenue
monrovia CA 91016
Manufacturer (Section G)
STAAR SURGICAL COMPANY
1911 walker avenue
monrovia CA 91016
Manufacturer Contact
michelle andres
1911 walker avenue
monrovia , CA 91016
6263037902
MDR Report Key6150079
Report Number2023826-2016-01731
Device Sequence Number1
Product CodeKYB
Report Source Manufacturer
Source Type USER FACILITY
Reporter Occupation
Type of Report Initial,Followup
Report Date 11/09/2016
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received12/06/2016
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator
Device MODEL NumberMSI-TM
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer02/10/2017
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received11/17/2016
Was Device Evaluated By Manufacturer? Yes
Is The Device Single Use? No
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

Patient TREATMENT DATA
Date Received: 12/06/2016 Patient Sequence Number: 1
Treatment
CARTRIDGE MODEL AND LOT NUMBER UNK
LENS MODEL AQ2010V - SERIAL NUMBER (B)(4)
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