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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 MICL 12.1
Medical Device Problem Code Optical Problem (3001)
Health Effect - Clinical Code Visual Disturbances (2140)
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 12.1mm, micl12.1, -11.5 diopter, implantable collamer lens was implanted into the patients right eye (od) on (b)(6) 2019 as a replacement lens due to excessive vault, glare/haloes and blurred vision.It was reported that the lens resolved the problem but the patient had some issues of glare at night.Additional information has been requested but none has been forthcoming.If additional information is received, a supplemental medwatch will be submitted.Reference mfr# 2023826-2020-00203 for initial lens.
 
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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 Key9634784
Report Number2023826-2020-00205
Device Sequence Number3414268
Product Code MTA
UDI-Device Identifier00841542102780
UDI-Public00841542102780
Combination Product (Y/N)N
Initial Reporter StateMA
Initial Reporter CountryUS
PMA/510(K) Number
P030016
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2019
Reporter Type Manufacturer
Report Source health professional
Initial Reporter Occupation Physician
Type of Report Initial
Report Date (Section B) 12/30/2019
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 Health Professional
Device Expiration Date04/30/2020
Device Model NumberMICL 12.1
Device Catalogue NumberN/A
Device Lot NumberN/A
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 12/30/2019
Initial Report FDA Received Date01/27/2020
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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