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

Model Number VTICM512.6

Device Problem Misfocusing (1401)

Patient Problems Glaucoma (1875); Headache (1880); Intraocular Pressure Increased (1937); Pupillary Block (2026); Blurred Vision (2137); Eye Pain (4467); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Type  Injury  

Event Description

The reporter indicated that a 12.6mm vticm512.6 implantable collamer lens of -11.00/1.5/86 (sphere/cylinder/axis) was implanted into the patient's left eye (os) on (b)(6) 2021.On (b)(6)-2023, yag was performed due to transient loss of bcva and elevated iop.Reportedly, "patient had intermittent transient vision loss resolved with laser pi.Her latest iop is 12mmhg.Possible intermittient results of pupilary block prior to laser pi in this case.

Manufacturer Narrative

H6: work order search found no similar complaints.Claim# (b)(6).

Manufacturer Narrative

Corrected data: b5- the patient also experienced grayish vision, visual field defect, ischaemic attack, and punctate epithelial erosions.H6- health effect- clinical code: 4581- grayish vision, visual field defect, ischaemic attack, and punctate epithelial erosions.Claim# (b)(4).

Manufacturer Narrative

Additional information: b5- the reporter indicated that the surgeon implanted a 12.6mm vticm5_12.6 implantable collamer lens of diopter -11.00/1.5/086 (sphere/cylinder/axis) into the patients left eye (os) on (b)(6) 2021.The patient experienced transient loss of bcva, yag was performed, elevated iop: 24 mmhg without pupil block and angle closure, periorbital eye pain, medication was prescribed, glaucoma, intermittent pupillary block, and headaches.On (b)(6) 2023 the lens was explanted.Reportedly "the patient developed os secondary glaucoma post icl, patient decided to remove both eye icl".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 enriquez ; 1911 walker avenue; monrovia, CA 91016 ; 8002927902
• MDR Report Key: 16766109
• MDR Text Key: 313558261
• Report Number: 2023826-2023-01337
• Device Sequence Number: 1
• Product Code: QCB
• 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,Followup,Followup
• Report Date: 03/20/2023

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: VTICM512.6
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/20/2023
• Initial Date FDA Received: 04/18/2023
• Supplement Dates Manufacturer Received: 03/24/2023; 05/11/2023
• Supplement Dates FDA Received: 05/02/2023; 05/11/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/11/2021
• 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 LOT #UNK; INJECTOR MODEL: MSI-PF LOT #UNK
• Patient Outcome(s): Required Intervention
• Patient Sex: Female