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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 Inadequacy of Device Shape and/or Size (1583)
Health Effect - Clinical Code No Clinical Signs, Symptoms or Conditions (4582)
Date of Event 08/20/2021
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
Weight: unk.Ethnicity: unk.Race: unk.Device evaluation not required.Claim # (b)(4).
 
Event or Problem Description
The reporter indicated the surgeon implanted a 12.6mm micl12.6 implantable collamer lens, -09.50 diopter, in the patients right eye (od) on (b)(6) 2021.The lens was explanted on (b)(6) 2021 due to excessive vaulting.The lens was replaced with a shorter lens and the problem was resolved.The cause of the event was unknown.
 
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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 Key12573692
Report Number2023826-2021-03857
Device Sequence Number17193828
Product Code MTA
UDI-Device Identifier00841542103015
UDI-Public00841542103015
Combination Product (Y/N)N
Initial Reporter StateCA
Initial Reporter CountryUS
PMA/510(K) Number
P030016
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2021
Device Explanted Year2021
Serviced by Third Party (Y/N)N
Reporter Type Manufacturer
Report Source health professional
Initial Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date (Section B) 09/13/2021
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 Date06/30/2023
Device Model NumberMICL12.6
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/22/2021
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 09/13/2021
Initial Report FDA Received Date10/04/2021
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 Age31 YR
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