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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
Device Problem Inadequacy of Device Shape and/or Size (1583)
Patient Problems Cataract (1766); Corneal Edema (1791); Hyphema (1911); Intraocular Infection (1933); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
Event Type  Injury  
Manufacturer Narrative
H6 - health effect clinical code: 4581 - lens impairment, iris prolapse, ocular hypertension, corneal endodermis damage, claim# (b)(4).
 
Event Description
An article published implantable collamer lens implantation (icl) versus small incision lenticule extraction (smile) in low to moderate myopia: study protocol for a randomized, non-inferiority trial - this study aimed to evaluated whether icl/ticl is comparable to smile for low to moderate myopia in terms of refractive outcomes at 3 and 18 months postoperatively.In this study it was indicated adverse events such as lens impairment, iris prolapse, hyphema, ocular hypertension, transient cornea edema, corneal endodermis damage, vault abnormality, surgery related cataract and intraocular infection, had occurred for patient with implantable collamer lenses.
 
Manufacturer Narrative
Corrected data: b5- originally the claim was determined to be reportable, but upon further review was determined to not meet definition of a complaint.However, the claim cannot be voided as an mdr has already been submitted.The article describes a prospective study that has not yet occurred.Claim# (b)(4).
 
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Brand Name
IMPLANTABLE COLLAMER LENS (ICL)
Type of Device
PHAKIC 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 ave
monrovia, CA 91016
MDR Report Key17495099
MDR Text Key320753011
Report Number2023826-2023-03441
Device Sequence Number1
Product Code MTA
Combination Product (y/n)N
Reporter Country CodeCH
PMA/PMN Number
P030016
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Foreign,Health Professional,Distributor
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 07/19/2023
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? No
Device Operator Health Professional
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received Not provided
Initial Date FDA Received08/09/2023
Supplement Dates Manufacturer Received10/26/2023
Supplement Dates FDA Received10/26/2023
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
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) Other;
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