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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 Inadequacy of Device Shape and/or Size (1583)
Health Effect - Clinical Code No Code Available (3191)
Date of Event 02/21/2019
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
Device evaluation: the lens was returned in liquid, in a vial.Visual inspection found one haptic torn.(b)(4).
 
Event or Problem Description
The reporter indicated the surgeon implanted a 12.6mm micl12.6 implantable collamer lens, -9.5 diopter, in the patients left eye (os) in (b)(6) 2019.The lens was explanted on (b)(6) 2019 due to excessive vaulting, narrowing of the angle and shallowing of the anterior chamber depth.The lens was exchanged for a shorter lens and the problem was resolved.The reporter indicated the cause of the event was 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 Key8445682
Report Number2023826-2019-00470
Device Sequence Number2839534
Product Code MTA
UDI-Device Identifier00841542103015
UDI-Public00841542103015
Combination Product (Y/N)N
Initial Reporter StateNC
Initial Reporter CountryUS
PMA/510(K) Number
P030016
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2019
Device Explanted Year2019
Reporter Type Manufacturer
Report Source health professional
Initial Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date (Section B) 02/22/2019
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 Date05/31/2020
Device Model NumberMICL12.6
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/21/2019
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 02/22/2019
Initial Report FDA Received Date03/22/2019
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 Age26 YR
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