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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 Known Impact Or Consequence To Patient (2692)
Date of Event 07/26/2017
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
Device evaluation: product evaluation found that the lens was returned in a specimen cup.Visual inspection found the haptic missing a piece and debris and clear residue on lens.Work order search: no similar complaints were reported for units within the same lot.(b)(4).
 
Event or Problem Description
The reporter indicated that the surgeon was loading a micl13.2, -15.5 diopter, implantable collamer lens on (b)(6) 2017.It was noticed that the lens tore while loading.The lens was not implanted and there was no patient contact.
 
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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 Key6818713
Report Number2023826-2017-01325
Device Sequence Number137109
Product Code MTA
UDI-Device Identifier00841542103404
UDI-Public00841542103404
Combination Product (Y/N)N
Initial Reporter StateGA
Initial Reporter CountryUS
PMA/510(K) Number
P030016
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source user facility
Initial Reporter Occupation Other
Type of Report Initial
Report Date (Section B) 07/31/2017
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 Date11/30/2017
Device Model NumberMICL13.2
Device Catalogue NumberN/A
Device Lot NumberN/A
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/15/2017
Was the Report Sent to FDA? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 07/31/2017
Initial Report FDA Received Date08/24/2017
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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