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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-PM
Device Problems Bent; Delivery System Failure; Plunger
Event Date 01/28/2016
Event Type  Malfunction  
Manufacturer Narrative

Device evaluated by manufacturer?: no. The product pertaining to this complaint was not returned for evaluation. However, the lens was returned and visual inspection found piece of haptic torn off and missing. The optic is torn at the loop haptic junction. There was evidence of dry clear surgical residue on optic surface. (b)(4).

 
Event Description

The reporter stated the surgeon implanted an aq2010v +06. 00 three piece silicone lens. The lens tore on insertion into the patient's right eye. The lens was removed and another lens, same model and size was implanted. There was no patient injury. Cause of lens tear was a faulty injector. The plunger tip on the injector was bent. No lot number was provided to injector. See mfr. #2023826-2016-0000120 for lens.

 
Manufacturer Narrative

Method: device history record review result: upon review of the device history record, there is nothing in the manufacturing, inspection and packaging process records to suggest a contributory factor to the complaint. Conclusion: based on the complaint history, work order search, medical review, device history record review and the lens evaluation, a specific root cause of the event could not be determined. 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 Key5464951
Report Number2023826-2016-00212
Device Sequence Number1
Product CodeKYB
Report Source Manufacturer
Source Type HEALTH PROFESSIONAL
Reporter Occupation
Type of Report Initial,Followup
Report Date 01/29/2016
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received02/26/2016
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator
Device MODEL NumberMSI-PM
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 Received04/12/2016
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Is The Device Single Use? No
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

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