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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 Unintended Movement (3026)
Health Effect - Clinical Code No Code Available (3191)
Date of Event 07/09/2019
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
(b)(4).No similar complaint type events reported for units within the same lot.(b)(4).
 
Event or Problem Description
A 13.2mm micl13.2 implantable collamer lens, -10.5 diopter, was implanted into the patient's eye on (b)(6) 2019.Reportedly, the lens flipped during insertion.It was removed and replaced with another icl.Attempts to obtain additional information have not been successful.
 
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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 Key8870926
Report Number2023826-2019-01402
Device Sequence Number16321913
Product Code MTA
UDI-Device Identifier00841542103305
UDI-Public00841542103305
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 Year2019
Reporter Type Manufacturer
Report Source company representative,health
Initial Reporter Occupation Physician
Type of Report Initial
Report Date (Section B) 07/10/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Operator of Device Health Professional
Device Expiration Date07/31/2020
Device Model NumberMICL13.2
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 07/10/2019
Initial Report FDA Received Date08/07/2019
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
Outcome Attributed to Adverse Event Required Intervention;
Patient Age28 YR
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