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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STAAR SURGICAL COMPANY IMPLANTABLE COLLAMER LENS (ICL); PHAKIC INTRAOCULAR LENS
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STAAR SURGICAL COMPANY IMPLANTABLE COLLAMER LENS (ICL); PHAKIC INTRAOCULAR LENS Back to Search Results
Model Number MICL13.2
Medical Device Problem Code Device Operates Differently Than Expected (2913)
Health Effect - Clinical Code No Patient Involvement (2645)
Date of Event 02/08/2018
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
Lens was returned in liquid, in lens case/vial.Visual inspection found a piece of haptic missing.No similar complaint type events were reported for units within the same lot.(b)(4).
 
Event or Problem Description
The reported indicated that a 13.2mm micl13.2, -10.5 diopter, implantable collamer lens tore during loading.There was no patient contact and the back up lens was used.The reporter stated that the cause of event was unknown.
 
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Brand Name
IMPLANTABLE COLLAMER LENS (ICL)
Common Device Name
PHAKIC INTRAOCULAR LENS
Manufacturer (Section D)
STAAR SURGICAL COMPANY
1911 walker avenue
monrovia CA 91016
MDR Report Key7339633
Report Number2023826-2018-00396
Device Sequence Number10809858
Product Code MTA
UDI-Device Identifier00841542103305
UDI-Public00841542103305
Combination Product (Y/N)N
Initial Reporter StateOK
Initial Reporter CountryUS
PMA/510(K) Number
P030016
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source health professional
Initial Reporter Occupation Other
Type of Report Initial
Report Date (Section B) 02/15/2018
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
Operator of Device Physician
Device Expiration Date01/31/2019
Device Model NumberMICL13.2
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/01/2018
Was the Report Sent to FDA? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 02/15/2018
Initial Report FDA Received Date03/14/2018
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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