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

Model Number	VTICM5_13.2
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Intraocular Pressure Increased (1937)
Type of Reportable Event	Serious Injury
Event or Problem Description
The reporter indicated the surgeon implanted a toric evo icl implantable collamer lens, into the patients eye.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.The lens remained implanted.Additional information has been requested but none has been forthcoming.
Additional Manufacturer Narrative
A2: unk.A3: unk.A4: unk.A5: unk.A6: unk.B3: unk.D4: expiration date unk.D6a: unk.D6b: unk.H4: unk.H6: health effect impact code: 4644 - iop lowering medications.Claim # (b)(4).
Additional Manufacturer Narrative
Additional data: h6 - work order search: no similar complaint was reported for units within the same lot.Corrected data: b5: the reporter indicated the surgeon implanted a 13.2mm vticm5_13.2 implantable collamer lens, -10.00/+1.5/071 (sphere/cylinder/axis), into the patients right eye (od).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.The lens remained implanted.At the most recent post-op, pressure has stabilized on medications and the patient is being monitored closely.Claim # (b)(4).

• 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: 18287965
• Report Number: 2023826-2023-05442
• Device Sequence Number: 17854258
• Product Code: QCB
• UDI-Device Identifier: 00840311311460
• UDI-Public: 00840311311460
• 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
• 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: 06/30/2026
• Device Model Number: VTICM5_13.2
• 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: 12/13/2023
• Initial Report FDA Received Date: 12/07/2023
• Supplement Report FDA Received Date: 12/19/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/26/2023
• 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