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

Model Number	VTICM5_12.6
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Intraocular Pressure Increased (1937); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Type of Reportable Event	Serious Injury
Event or Problem Description
The reporter indicated the surgeon implanted a 12.6mm vticm5_12.6 implantable collamer lens, 10.00/+1.5/069 (sphere/cylinder/axis), into the patients left eye (os).At one month post-op, the patient had persistent elevated intraocular pressure (iop), which was being treated with iop lowering medications.The patient had no symptoms of angle closure and no signs of inflammation.Current post-op finds the pressure has stabilized on medication.The patient is being watched closely.The lens remained implanted.Additional information has been requested but none has been forthcoming.
Additional Manufacturer Narrative
H6: health effect impact code: 4644 - iop lowering medications.H6 - work order search: no similar complaint was reported for units within the same lot.Claim # (b)(4).
Additional Manufacturer Narrative
Corrected data: h6 - health effect clinical code: 4581 (narrowing of angles).G3 - corrected date for supplemental mdr #1.Claim#: (b)(4).
Additional Manufacturer Narrative
B5- the reporter indicated the surgeon implanted a 12.6mm vticm5_12.6 implantable collamer lens, -10.00/+1.5/069 (sphere/cylinder/axis), into the patients left eye (os).At one month post-op, the patient had persistent elevated intraocular pressure (iop), which was being treated with iop lowering medications.The patient had no symptoms of angle closure and no signs of inflammation.Narrowing of angle was also noted and current post-op finds the pressure has stabilized on medication.The patient is being watched closely.The lens remained implanted.

• Brand Name: IMPLANTABLE COLLAMER LENS (ICL)
• Common Device Name: 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: 18337478
• Report Number: 2023826-2023-05678
• Device Sequence Number: 17827563
• Product Code: QCB
• UDI-Device Identifier: 00841542114974
• UDI-Public: 00841542114974
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: P030016
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/16/2023

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
• Operator of Device: Health Professional
• Device Expiration Date: 12/31/2024
• Device Model Number: VTICM5_12.6
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/16/2023
• Supplement Date Received by Manufacturer: 01/04/2024; 01/04/2024
• Initial Report FDA Received Date: 12/15/2023
• Supplement Report FDA Received Date: 02/07/2024; 02/07/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/26/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: UNK.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown