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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 Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
Event Type  Injury  
Manufacturer Narrative
H6 - health effect clinical code: 4581 - redness, photophobia, iris chaffing.Claim# (b)(4).
 
Event Description
During an ascrs meeting a presentation indicated that there was a case study that indicated that a patient that received implantable collamer lens of -7.50 diopter, into the right eye (od).It noted there was lens rotation and at 4 months postoperative, the patient complained of redness and photophobia.During examination there was iris chafing in this patient.The lens was repositioned and this resolved the problem.
 
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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 avenue
monrovia, CA 91016
MDR Report Key19187743
MDR Text Key341119671
Report Number2023826-2024-01964
Device Sequence Number1
Product Code MTA
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
Report Date 04/10/2024
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 04/10/2024
Initial Date FDA Received04/25/2024
Was Device Evaluated by Manufacturer? No
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;
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