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 Inflammation (1932); Intraocular Pressure Increased (1937); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 08/24/2023

Event Type  Injury  

Manufacturer Narrative

A review of the device labeling was completed.Elevated iop and pigment dispersion are identified in the labeling as known adverse events from icl implantation.The dfu adequately provides instructions for icl implantation and includes known adverse events associated with lens implantation.The dfu statements include: adverse reactions and complications due to or following surgery and implantation of any evo|evo+icl may include, but are not limited to: uveitis/iritis, iop elevation from baseline, iris pigment dispersion, secondary surgical intervention to remove the lens.Even though the causality was attributed to the device an exact cause could not be determined as the event could be multifactorial in nature including patient and/or procedure related factors.The lens was not returned to date.H6- health effect- clinical code 4581: pigment dispersion.H6 - type of investigation - lens work order search: no similar complaint type events reported for units within the same lot.Claim# (b)(4).

Event Description

The reporter indicated that a 12.6mm vicm5 implantable collamer lens of -5.00d was implanted into the patient's left eye (os) on (b)(6) 2023.The patient underwent bilateral icl implantation on the same day.Elevated iop was noted approximately 3 mos.Post-op.Pigment dispersion and inflammation are observed on an unknown date.At patient request lens explant was performed on (b)(6) 2023 by a different surgeon who continues to monitor the iop.The patient refuses to return to the implanting surgeon.The reporter did not provide last visual acuity or ocular status as the patient is under the care of a different medical provider.Based on clinic reported pre-op wtw & acd, the surgeon implanted a shorter lens than suggested by the directions for use.In the reporter's opinion the cause of the event was due to the device.Additional information has been requested but none has been forthcoming.If additional information is received a supplemental medwatch report will be submitted.

• 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 ; 6263037902
• MDR Report Key: 18700891
• MDR Text Key: 335294410
• Report Number: 2023826-2024-00568
• 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
• Report Date: 01/16/2024

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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/16/2024
• Initial Date FDA Received: 02/14/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 11/04/2022
• 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 W/FTP, LOT# UNK.
• Patient Outcome(s): Required Intervention
• Patient Age: 34 YR
• Patient Sex: Female