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

Model Number	VTICM5_13.2
Medical Device Problem Code	Inadequacy of Device Shape and/or Size (1583)
Health Effect - Clinical Codes	Inflammation (1932); Discomfort (2330); 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 13.2mm vticm5_13.2 implantable collamer lens, -09.00/+2.0/093 (sphere/cylinder/axis), into the patients left eye (os) on (b)(6) 2023.Shallow anterior chamber (ac) and high vault was noted.The lens remained implanted.A course of steroids was administered.Post-op, the patients ocular discomfort has mostly subsided already.Additional information has been requested but none has been forthcoming.
Additional Manufacturer Narrative
Weight: unk.Ethnicity: unk.Race: unk.Date of event: unk.Health effect impact code: 4644 - steroids work order search: no similar complaint was reported for units within the same lot.Claim #(b)(4).
Additional Manufacturer Narrative
Corrected data/ additional data: b5: the reporter indicated that the surgeon implanted a 13.2mm vticm5_13.2 implantable collamer lens of diopter -9.0/+2.0/093 (sphere/cylinder/axis) into the patient's left eye (os) on (b)(6) 2023.The patient experienced excessive vault, shallow ac, iris pigment loss, iris prolapse, inflammation and medication was prescribed.Reportedly "vision is great and refractive outcome is very good.However, her ac in both eyes is quite shallow.Vault is high (approx 1500-2000 micron)." and "i have started a course of steroids to counter any mild underlying inflammation".It was later reported, "shallow vault.Ucva 6/5.Clear lens.Iris pigment loss from prolapse during surgery.Iop 14".The lens remains implanted.H6: health impact code: "4614" should be added.H6: health effect- clinical code: "4581- shallow ac, iris prolapse, iris pigment loss " and "1932" should be added.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: 17704497
• Report Number: 2023826-2023-03871
• Device Sequence Number: 20519615
• Product Code: QCB
• UDI-Device Identifier: 00840311311729
• UDI-Public: 00840311311729
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: P030016
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/14/2023

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: 05/31/2026
• 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: Not provided
• Supplement Date Received by Manufacturer: 01/22/2024
• Initial Report FDA Received Date: 09/07/2023
• Supplement Report FDA Received Date: 01/24/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/09/2023
• 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: CARTRIDGE MODEL SFC45 - LOT # UNK.; FOAM TIP PLUNGER MODEL FTP - LOT # UNK.; INJECTOR MODEL MSI-PF - LOT # UNK.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Female