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

Model Number VICM5 12.6

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Uveitis (2122); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 11/22/2023

Event Type  Injury  

Manufacturer Narrative

H6 - health effect clinical code 4581: pigment dispersion h6 - work order search: no similar complaint type events were reported for units within the same lot.Claim# (b)(4).

Event Description

The reporter indicated that the surgeon implanted a 12.6mm vicm5_12.6.-2.25 diopter implantable collamer lens into the patient's left eye (os) on (b)(6) 2023.Lens was explanted on (b)(6) 2023 due to pigment dispersion and prolonged post-op anterior uveitis.Problem not resolved.Cause of event unknown.Reportedly, anterior chamber activities persist and patient is under gutt pred forte 1%, gutt vigamox, gutt irmocomod, gutt glanatec.

Manufacturer Narrative

H6 - one additional similar complaint type event within associated lots was found (fellow od)).Claim #(b)(4).

Manufacturer Narrative

H3: device evaluation: the lens was returned in a microcentrifuge vial with residue/debris on the lens.Visual inspection found haptic torn with foreign material on the lens surface, specifically debris and residue throughout the lens.Claim#: (b)(4).

• 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 SURGICAL COMPANY; 1911 walker avenue; monrovia CA 91016
• Manufacturer Contact: joselene muniz ; 1911 walker avenue; monrovia, CA 91016
• MDR Report Key: 18427346
• MDR Text Key: 331812613
• Report Number: 2023826-2024-00010
• Device Sequence Number: 1
• Product Code: MTA
• Combination Product (y/n): N
• Reporter Country Code: MY
• PMA/PMN Number: P030016
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 03/11/2024

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 Number: VICM5 12.6
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/14/2023
• Initial Date FDA Received: 01/02/2024
• Supplement Dates Manufacturer Received: 03/08/2024; 03/11/2024
• Supplement Dates FDA Received: 03/08/2024; 03/11/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/22/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: CARTRIDGE MODEL#SFC-45,LOT#UNK.; FOAMTIPPLUNGER MODEL#FTP,LOT#UNK.; INJECTOR MODEL#MSI-PF,LOT#UNK.
• Patient Outcome(s): Required Intervention
• Patient Age: 26 YR
• Patient Sex: Female