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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 Inadequacy of Device Shape and/or Size (1583)
Health Effect - Clinical Code No Code Available (3191)
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
Weight: unk.Ethnicity: unk.Race: unk.Date of event: unk.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 13.2mm micl13.2 implantable collamer lens, -8.0 diopter, in the patients left eye (os) in (b)(6) 2019.The lens was explanted on (b)(6) 2019 due to excessive vaulting and narrowing of the angle.The lens was exchanged for a shorter 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 Key8492947
Report Number2023826-2019-00567
Device Sequence Number11253433
Product Code MTA
UDI-Device Identifier00841542103251
UDI-Public00841542103251
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) 03/15/2019
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 Date08/31/2020
Device Model NumberMICL13.2
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/29/2019
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 03/15/2019
Initial Report FDA Received Date04/08/2019
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;
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