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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 VICM513.2
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Toxic Anterior Segment Syndrome (TASS) (4469)
Event Date 03/12/2024
Event Type  Injury  
Manufacturer Narrative
A4-a6:unk.H6: work order search: no similar complaints within associated lots were found.Manufacturer's narrative: a review of the device labeling was completed.Iritis is identified in the labeling as a known potential adverse event following icl implantation.The dfu provides the surgeon instruction for complete ovd removal.Precaution: (6) after inserting this product, aspirate the viscoelastic substance completely from inside the eye.Do not use highly viscous viscoelastic substances that are difficult to aspirate completely.Toxic anterior segment syndrome (tass) is an acute sterile postoperative inflammation that can occur after uncomplicated or complicated intraocular surgery.While improper sterilization and contamination of surgical instruments remains the most common risk factor associated with tass, ocular viscoelastic, and improper preparation of antibiotics for intracameral injection may also lead to tass.An exact cause could not be determined as the event could be multifactorial in nature including patient and/or procedure related factors.A supplemental medwatch report will be submitted if additional information is received.Claim# (b)(4).
 
Event Description
The reporter indicated that a 13.2mm vicm513.2 implantable collamer lens of a -3.5 diopter was implanted into the patient's right eye (od).Concomitant product information used intraoperatively including viscoelastic and delivery system type were not provided.On (b)(6) 2024, day 1, toxic anterior segment syndrome (tass) was diagnosed.Pupil fibrin was observed.Antibiotic and steroid ophthalmic drops as well as oral steroids were prescribed.Visual acuity was noted as of (b)(6) 2024 to be improved from 1.0 (~20/20) to 1.2 (~20/15).The lens remains implanted.
 
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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
800 royal oaks dr. suite: 210
monrovia, CA 91016
6263037902
MDR Report Key19102334
MDR Text Key340103278
Report Number2023826-2024-01286
Device Sequence Number1
Product Code QCB
UDI-Device Identifier00840311300808
UDI-Public00840311300808
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
P030017
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
Report Date 03/15/2024
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
Device Model NumberVICM513.2
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 03/15/2024
Initial Date FDA Received04/12/2024
Date Device Manufactured10/30/2023
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;
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