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

Model Number VTICMO13.7

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

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

Event Date 02/24/2024

Event Type  Injury  

Event Description

The reporter indicated the surgeon implanted a 13.7mm vticmo13.7 implantable collamer lens, -15.00/+4.0/075 (sphere/cylinder/axis), in the patients left eye (os), on (b)(6) 2023.The lens was reported as excessive vaulting, angle closure with elevated iop.The pupil was unreactive (fixed).A new addition pi (yag) was performed on (b)(6) 2024.Post-op, the cornea is clear, ac slightly quiet and deep enough but the vault still too high and angles almost closed.The patient is on glaucoma medication for 2 months now to control iop.The cause of the event was the device.Additional information has been requested but none has been forthcoming.

Manufacturer Narrative

A4: unk.A5: unk.A6: unk.H6: health impact- clinical code: 4581 - unreactive pupil, angle closure.H6: health effect impact code - additional medications: 4644 - glaucoma medication.H6: health impact - additional surgery: 4625 - addition of new pi.H6 - work order search: no similar complaint was reported for units within the same lot.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 ; 6263037902
• MDR Report Key: 18914530
• MDR Text Key: 337788330
• Report Number: 2023826-2024-01008
• Device Sequence Number: 1
• Product Code: QCB
• UDI-Device Identifier: 00840311333202
• UDI-Public: 00840311333202
• Combination Product (y/n): N
• Reporter Country Code: SA
• 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: 02/27/2024

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: VTICMO13.7
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/27/2024
• Initial Date FDA Received: 03/15/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 02/24/2023
• 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: 31 YR
• Patient Sex: Male