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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 No Apparent Adverse Event (3189)
Health Effect - Clinical Code No Known Impact Or Consequence To Patient (2692)
Date of Event 03/21/2018
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
Lens work order search: no similar complaint type events reported for units within the same lot.Claim# (b)(4).
 
Event or Problem Description
The reporter indicated that the surgeon implanted a 12.6mm micl12.6 implantable collamer lens, -12.0 diopter, into the patient's eye on (b)(6) 2018.Intraoperatively, the lens was successfully exchanged with an alternate lens.The reason for the exchange is unknown.
 
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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 Key7906909
Report Number2023826-2018-01442
Device Sequence Number16557714
Product Code MTA
UDI-Device Identifier00841542103060
UDI-Public00841542103060
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 Year2018
Device Explanted Year2018
Reporter Type Manufacturer
Report Source company representative
Initial Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date (Section B) 08/30/2018
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 Health Professional
Device Expiration Date12/31/2018
Device Model NumberMICL12.6
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 08/30/2018
Initial Report FDA Received Date09/25/2018
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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