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

Model Number	VTICM5_13.2
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); No Apparent Adverse Event (3189)
Health Effect - Clinical Codes	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/13/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
The reporter indicated that a 13.2mm, vticm5_13.2, -5.50/1.0/078 (sphere/cylinder/axis), implantable collamer lens was implanted into the patient's left eye (os) on (b)(6) 2023.Oval shape pupil at temporal was observed.Lens remains implanted.Additional information has been requested but none has been forthcoming.
Additional Manufacturer Narrative
H6 - health effect clinical code 4581: oval shape pupil at temporal.H6 - work order search: no similar complaint type events were reported for units within the same lot.Claim#(b)(4).
Additional Manufacturer Narrative
Additional information: b5: the reporter indicated that the surgeon implanted a 13.2mm vticm5_13.2 implantable collamer lens of diopter -5.0/+1.0/78 (sphere/cylinder/axis)into the patient's left eye (os) on (b)(6) 2023.The patient experienced pupil ovalisation, pigment dispersion and medication was prescribed.On (b)(6) 2023 the lens was exchanged with the same mode, shorter length lens and the problem was resolved.Reportedly "case resolved, va and vaulting is good, iop stable with 2 antiglaucoma drops.Dr.Will monitor." the reporter indicated the cause of the event was unknown.H6: health effect- clinical code: "4581- pupil ovalisation and pigment dispersion " should be added.H6: health effect- impact code: "4629" and "4644" should be added."2199" should be removed.H6: medical device problem code: "3189" should be removed and "2993" 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
• MDR Report Key: 18075206
• Report Number: 2023826-2023-04921
• Device Sequence Number: 20749518
• Product Code: QCB
• UDI-Device Identifier: 00840311311088
• UDI-Public: 00840311311088
• Combination Product (Y/N): N
• Initial Reporter Country: MY
• PMA/510(K) Number: P030016
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/17/2023

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 06/30/2026
• Device Model Number: VTICM5_13.2
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• 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: 10/17/2023
• Supplement Date Received by Manufacturer: 12/05/2023
• Initial Report FDA Received Date: 11/06/2023
• Supplement Report FDA Received Date: 12/08/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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: CARTRIDGE MODEL#SFC-45.; FOAMTIPPLUNGER MODEL#FT.; INJECTOR MODEL#MSI-PF.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 38 YR
• Patient Sex: Female