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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 MICL12.6
Medical Device Problem Code Device Operates Differently Than Expected (2913)
Health Effect - Clinical Codes Blurred Vision (2137); No Consequences Or Impact To Patient (2199)
Date of Event 12/06/2017
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 a 12.6mm micl12.6 implantable collamer lens, -11.0 diopter, was implanted and refractive surprise was observed after surgery.The reported stated that time corrected the problem and that the lens remains implanted.Lens removal was not necessary, patient is doing great and is very happy.
 
Additional Manufacturer Narrative
Corrected data: (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 Key7169824
Report Number2023826-2018-00053
Device Sequence Number1475648
Product Code MTA
UDI-Device Identifier00841542103046
UDI-Public00841542103046
Combination Product (Y/N)N
Initial Reporter StateAZ
Initial Reporter CountryUS
PMA/510(K) Number
P030016
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2017
Reporter Type Manufacturer
Report Source health professional
Initial Reporter Occupation Physician
Type of Report Initial,Followup
Report Date (Section B) 12/07/2017
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 Date04/30/2019
Device Model NumberMICL12.6
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Initial Date Received by Manufacturer 12/07/2017
Supplement Date Received by Manufacturer03/15/2018
Initial Report FDA Received Date01/05/2018
Supplement Report FDA Received Date03/15/2018
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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