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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 Codes Intraocular Pressure Increased (1937); No Code Available (3191)
Date of Event 10/16/2018
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
Pt info: unk.(b)(4).Device evaluation: lens was returned liquid, in a specimen cup.Visual inspection found a torn haptic.(b)(4).
 
Event or Problem Description
The reporter indicated that a 13.2mm, micl13.2, -10.50 diopter, implantable collamer lens was implanted into the patient's left eye (os) on (b)(6) 2018.On (b)(6) 2018 the lens was exchanged for a shorter length lens due to excessive vault and angle closure with elevated iop.This exchange 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 Key8068768
Report Number2023826-2018-01674
Device Sequence Number11332542
Product Code MTA
UDI-Device Identifier00841542103305
UDI-Public00841542103305
Combination Product (Y/N)N
Initial Reporter StateCO
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 health professional
Initial Reporter Occupation Other Health Care Professional
Type of Report Initial
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 Date06/30/2020
Device Model NumberMICL13.2
Device Catalogue NumberN/A
Device Lot NumberN/A
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/01/2018
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 10/17/2018
Initial Report FDA Received Date11/14/2018
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
Concomitant Medical Products
and Therapy/Usage Dates
CARTRIDGE- SFC-45, LOT#UNK
Outcome Attributed to Adverse Event Required Intervention;
Patient Age29 YR
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