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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 MICL 12.6
Medical Device Problem Codes Off-Label Use (1494); Inadequacy of Device Shape and/or Size (1583)
Health Effect - Clinical Codes Intraocular Pressure Increased (1937); No Code Available (3191)
Date of Event 03/01/2019
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
Lens was returned in biohazard zip loc bag, in vial, in liquid.Visual inspection found no visible damage to lens.(b)(4).
 
Event or Problem Description
The reporter indicated that the surgeon implanted a 12.6mm micl12.6, -11.0 diopter, implantable collamer lens into the patients left eye (os) on (b)(6) 2019.The lens was removed and replaced on (b)(6) 2019 for a shorter length lens due to excessive vault and angle closure with elevated iop (65 mmhg).This resolved the problem.
 
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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 Key8471518
Report Number2023826-2019-00457
Device Sequence Number1963014
Product Code MTA
UDI-Device Identifier00841542103046
UDI-Public00841542103046
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
Device Explanted Year2019
Reporter Type Manufacturer
Report Source health professional
Initial Reporter Occupation Physician
Type of Report Initial
Report Date (Section B) 03/05/2019
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 NumberMICL 12.6
Device Catalogue NumberN/A
Device Lot NumberN/A
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 03/05/2019
Initial Report FDA Received Date04/01/2019
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 Age40 YR
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