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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STAAR SURGICAL COMPANY IMPLANTABLE COLLAMER LENS (ICL); PHAKIC TORIC INTRAOCULAR LENS

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STAAR SURGICAL COMPANY IMPLANTABLE COLLAMER LENS (ICL); PHAKIC TORIC INTRAOCULAR LENS Back to Search Results
Model Number TMICL13.2
Device Problems Device Dislodged or Dislocated (2923); Optical Problem (3001)
Patient Problems Corneal Edema (1791); Headache (1880); Blurred Vision (2137); Eye Pain (4467)
Event Date 04/26/2023
Event Type  Injury  
Manufacturer Narrative
(b)(4).
 
Event Description
The reporter indicated that the surgeon implanted a 13.2mm tmicl13.2; -12.5/+1.00/179 (sphere/cylinder/axis) implantable collamer lens into the patient's right eye (od) on (b)(6)2023.The patient experienced lens rotation, the surgeon also noted headaches, corneal edema, blurry vision and glares.Lens remains implanted.The cause of the event was reported as user error - preop axis was not accurate based on the topography and auto-refract axis of about 49 degrees and it was a pre-op measurement error not an issue with the lens itself.
 
Manufacturer Narrative
B5 - it was also reported that the patient had eye pain and medication was used, timolol and diamox.Claim#:(b)(4).
 
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Brand Name
IMPLANTABLE COLLAMER LENS (ICL)
Type of Device
PHAKIC TORIC INTRAOCULAR LENS
Manufacturer (Section D)
STAAR SURGICAL COMPANY
1911 walker avenue
monrovia CA 91016
Manufacturer (Section G)
STAAR SUGICAL COMPANY
1911 walker avenue
monrovia CA 91016
Manufacturer Contact
joselene muniz
1911 walker avenue
monrovia, CA 91016
MDR Report Key17935878
MDR Text Key326142233
Report Number2023826-2023-04537
Device Sequence Number1
Product Code QCB
UDI-Device Identifier00841542116923
UDI-Public00841542116923
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
P030016
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 10/04/2023
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? Yes
Device Operator Health Professional
Device Model NumberTMICL13.2
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 10/04/2023
Initial Date FDA Received10/13/2023
Supplement Dates Manufacturer Received12/26/2023
Supplement Dates FDA Received12/26/2023
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured02/07/2023
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age35 YR
Patient SexFemale
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