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

Model Number VTICMO12.6

Device Problems Misfocusing (1401); Off-Label Use (1494); Adverse Event Without Identified Device or Use Problem (2993); Unintended Movement (3026)

Patient Problems Cataract (1766); Intraocular Pressure Increased (1937); Blurred Vision (2137); Eye Pain (4467)

Event Date 01/17/2024

Event Type  Injury  

Manufacturer Narrative

A4: unk.A5: unk.A6: unk.H6: health impact - additional surgery: 4625 - cataract surgery, iol implanted.H6 - device code: 1494 - this lens model is contraindicated for patients with age less than that of 21 years.H6 - work order search: no similar complaint was reported for units within the same lot.Claim # (b)(4).

Event Description

The reporter indicated the surgeon implanted a 12.6mm vticmo12.6 implantable collamer lens, -17.00/+1.5/115 (sphere/cylinder/axis), in the patients right eye (od), on (b)(6) 2024.The lens was explanted on (b)(6) 2024 due to lens was implanted upside down.The patient experienced light pain and blurred vision.The icl lens had contact with the crystalline lens during surgery and a cataract was observed.Elevated intraocular pressure was confirmed in the eye.Phacoemulsification (cataract surgery) was performed and an iol was implanted.The patient is pseudophakia.

• 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: 18761662
• MDR Text Key: 336050550
• Report Number: 2023826-2024-00761
• Device Sequence Number: 1
• Product Code: QCB
• Combination Product (y/n): N
• Reporter Country Code: GR
• 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: 01/29/2024

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: VTICMO12.6
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/08/2024
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/22/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 04/05/2023
• 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: 19 YR
• Patient Sex: Female