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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 Code No Code Available (3191)
Date of Event 02/21/2018
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
Device evaluation: product evaluation found that the lens was returned in liquid in a lens vial.Visual inspection found the haptic torn.(b)(4).
 
Event or Problem Description
The reporter indicated that the surgeon implanted a 12.6 mm micl12.6, -11.0 diopter, implantable collamer lens in the patient's right eye (od) on (b)(6) 2018.The lens had to be explanted because the "lens went in wrong".A back-up lens was implanted.There was no widened incision and no sutures used.Attempts at obtaining additional information have not been forthcoming.
 
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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 Key7398184
Report Number2023826-2018-00494
Device Sequence Number723135
Product Code MTA
UDI-Device Identifier00841542103046
UDI-Public00841542103046
Combination Product (Y/N)N
Initial Reporter StateUT
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 user facility
Initial Reporter Occupation Other
Type of Report Initial
Report Date (Section B) 03/06/2018
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 Date09/30/2019
Device Model NumberMICL12.6
Device Catalogue NumberN/A
Device Lot NumberN/A
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/15/2018
Was the Report Sent to FDA? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 03/06/2018
Initial Report FDA Received Date04/04/2018
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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