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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 Visual Disturbances (2140); Halo (2227)
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
Device evaluation: lens was returned dry, in a specimen cup.Visual inspection found a torn haptic and residue on the lens surface.Work order search: no similar complaint type events were reported for units within the same lot.(b)(4).
 
Event or Problem Description
The reporter indicated the surgeon implanted a 12.6mm micl12.6, -10.5 diopter, implantable collmer lens into the right eye (od) on (b)(6) 2017.The lens was explanted on (b)(6) 2018 due to halos and glare.It was reported that the halos and glares were noticed on the same day as the implant surgery.There is no plans to implant another lens.Patient is stable but still has glare from pi.
 
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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 Key7578068
Report Number2023826-2018-00864
Device Sequence Number1979908
Product Code MTA
UDI-Device Identifier00841542103039
UDI-Public00841542103039
Combination Product (Y/N)N
Initial Reporter StateFL
Initial Reporter CountryUS
PMA/510(K) Number
P030016
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2017
Device Explanted Year2018
Reporter Type Manufacturer
Report Source health professional
Initial Reporter Occupation Other
Type of Report Initial
Report Date (Section B) 05/10/2018
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 Physician
Device Expiration Date04/30/2019
Device Model NumberMICL12.6
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/23/2018
Was the Report Sent to FDA? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 05/10/2018
Initial Report FDA Received Date06/07/2018
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;
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