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

Model Number VTICM5_12.6

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

Patient Problems Intraocular Pressure Increased (1937); Blurred Vision (2137)

Event Date 02/02/2024

Event Type  Injury  

Manufacturer Narrative

H6 - type of investigation: 4110 - 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 the surgeon implanted a 12.6mm vticm5_12.6; -13.0/1.5/121 (sphere/cylinder/axis) implantable collamer lens into the patient's left eye (os) on (b)(6)2024.The surgeon reports there is refractive surprise.The patient is on monoprost for iop.Lens remains implanted.The cause of the event was reported as unknown.The problem is not resolved.

Manufacturer Narrative

It was later reported that on (b)(6) 2024 the lens was explanted and on this same date replaced with a same length but different power lens and the problem was resolved.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 SURGICAL COMPANY; 1911 walker avenue; monrovia CA 91016
• Manufacturer Contact: joselene muniz ; 1911 walker avenue; monrovia, CA 91016
• MDR Report Key: 19076765
• MDR Text Key: 339773593
• Report Number: 2023826-2024-01726
• Device Sequence Number: 1
• Product Code: QCB
• UDI-Device Identifier: 00840311308163
• UDI-Public: 00840311308163
• Combination Product (y/n): N
• Reporter Country Code: SP
• PMA/PMN Number: P030016
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/21/2024

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: VTICM5_12.6
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/21/2024
• Initial Date FDA Received: 04/09/2024
• Supplement Dates Manufacturer Received: 04/23/2024
• Supplement Dates FDA Received: 04/24/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 12/21/2023
• 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.; FOAM TIP PLUNGER MODEL-FTP, LOT#-UNK.; INJECTOR MODEL-MSI-PF, LOT#-UNK.
• Patient Outcome(s): Required Intervention
• Patient Age: 57 YR
• Patient Sex: Male