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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 Scratched Material (3020)
Health Effect - Clinical Code No Patient Involvement (2645)
Date of Event 03/22/2018
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
No similar complaint type events were reported for units within the same lot.(b)(4).
 
Event or Problem Description
The reporter indicated that the surgeon noticed a scratch on a 13.2 mm micl13.2, -10.0 diopter, implantable collamer lens while loading it under a microscope.There was no patient contact with the lens.A back up lens was used, but the procedure was not intraoperative.
 
Additional Manufacturer Narrative
Device evaluation: lens was returned in lens vial in liquid.Visual inspection found optic and haptic tear.Claim # (b)(4).
 
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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 Key7449228
Report Number2023826-2018-00601
Device Sequence Number16631724
Product Code MTA
UDI-Device Identifier00841542103299
UDI-Public00841542103299
Combination Product (Y/N)N
Initial Reporter StateMO
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,Followup
Report Date (Section B) 03/23/2018
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 Date11/30/2018
Device Model NumberMICL13.2
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/27/2018
Was the Report Sent to FDA? No
Initial Date Received by Manufacturer 03/23/2018
Supplement Date Received by Manufacturer07/27/2018
Initial Report FDA Received Date04/20/2018
Supplement Report FDA Received Date08/09/2018
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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