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

Model Number VTICM5_13.2

Device Problem Inadequacy of Device Shape and/or Size (1583)

Patient Problems Intraocular Pressure Increased (1937); Pain (1994); Blurred Vision (2137); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Type  Injury  

Event Description

The reporter indicated that a 13.2mm vticm5_13.2 implantable collamer lens of -10.0/3.5/094 (sphere/cylinder/axis) was implanted into the patient's left eye (os) on (b)(6) 2023.On (b)(6) -2023 the lens was explanted due to excessive vault, elevated iop, angle closure and pigment dispersion.A replacement lens of shorter length was later implanted and the problem resolved (vault).

Manufacturer Narrative

Health effect- clinical code 4581: angle closure, pigment dispersion.Type of investigation - lens work order search: no similar complaint type events reported for units within the same lot.Claim# (b)(4).

Manufacturer Narrative

Corrected data: b5: the reporter indicated the surgeon implanted a 13.2mm vticm5_13.2 implantable collamer lens of diopter -8.5/+1.5/104 (sphere/cylinder/axis) into the patient's left eye (os) on (b)(6) 2023.The patient experienced an excessive vault, elevated iop, angle closure, pigment dispersion, pain, blurred vision and medication was prescribed.On (b)(6) 2023 the lens was explanted and replaced with the same model and power but shorter length and the problem was resolved.Status of the eye: "iop normal with single drug glaucoma therapy".Additional information provided - "waiting for iop to lower further.The angles are open now.Pigment dispersion still present".The cause of the event was the device.Cause details provided: "raised iop due to angle closer and high vault and pigment dispersion".H6: health effect- clinical code: "2137" and "1994" should be added.H6: health effect- impact code: "4644" should be added.Claim#: (b)(4).

• 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 ; 1911 walker avenue; monrovia, CA 91016
• MDR Report Key: 17970222
• MDR Text Key: 326118059
• Report Number: 2023826-2023-04631
• Device Sequence Number: 1
• Product Code: QCB
• Combination Product (y/n): N
• Reporter Country Code: IN
• 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
• Report Date: 09/25/2023

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
• Device Model Number: VTICM5_13.2
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/25/2023
• Initial Date FDA Received: 10/19/2023
• Supplement Dates Manufacturer Received: 11/09/2023
• Supplement Dates FDA Received: 11/09/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/23/2022
• 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.; INJECTOR MODEL: MSI-PF, LOT# UNK.
• Patient Outcome(s): Required Intervention
• Patient Sex: Male