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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 13.2
Medical Device Problem Code Unintended Movement (3026)
Health Effect - Clinical Code No Code Available (3191)
Date of Event 07/20/2020
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
(b)(4).
 
Event or Problem Description
The reporter indicated that the surgeon implanted upside down a 13.2mm micl13.2, -3.5 diopter, implantable collamer lens, into the patient's left eye on (b)(6) 2020.There was patient contact (lens touched the eye) with no patient injury.The lens was removed and exchanged on (b)(6) 2020 with a same size, similar (sphere/cylinder/axis) lens.The problem was resolved.Cause of the event is reported as user error.Reportedly, surgeon "did not recognize that lens was implanted upside down at surgery, but it was evident at the one-week post-op visit.".
 
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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
MDR Report Key10426599
Report Number2023826-2020-01772
Device Sequence Number11513069
Product Code MTA
UDI-Device Identifier00841542103169
UDI-Public00841542103169
Combination Product (Y/N)N
Initial Reporter CountryUS
PMA/510(K) Number
P030016
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2020
Device Explanted Year2020
Reporter Type Manufacturer
Report Source health professional
Initial Reporter Occupation Physician
Type of Report Initial
Report Date (Section B) 07/29/2020
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 Date02/28/2022
Device Model NumberMICL 13.2
Device Catalogue NumberN/A
Device Lot NumberN/A
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 07/29/2020
Initial Report FDA Received Date08/19/2020
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 Age34 YR
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