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

Model Number	VICM5 13.2
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	02/16/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
The reporter indicated that the surgeon implanted an implantable collamer lens of unknown model and size into the patient's left eye (os) on an unknown date.Reportedly, "unexpected diffused cornea endothelial failure in a quiet non traumatic uneventful left eye icl surgery.Will continue to monitor the eye." to the best of our knowledge the lens remains implanted.No further information has been provided.Attempts to obtain additional information have not been successful.If additional information is received a supplemental medwatch report will be submitted.
Additional Manufacturer Narrative
(b)(4).
Additional Manufacturer Narrative
B3: date of event: 16-feb-2024 should be added to the initial mdr.B5: corrected to: "the reporter indicated that the surgeon implanted a13.2mm vicm5_13.2 implantable collamer lens of diopter -3.0 into the patient's left eye (os) on (b)(6) 2024.Reportedly, "unexpected diffused cornea endothelial failure in a quiet non traumatic uneventful left eye icl surgery." the lens remains implanted.Reportedly, "fogginess is less.Still monitoring." the cause of the event was reported as unknown." in the initial mdr.D4: model#: vicm5 13.2mm should be added to the initial mdr.D4: serial#: (b)(6) should be added to the initial mdr.D4: expiration date: 31-aug-2026 should be added to the initial mdr.D4: udi#: (b)(4) should be added to the initial mdr.H4: device manufacture date: 15-sep-2023 should be added to the initial mdr.H6: type of investigation: 4110 should be added to the initial mdr.H6: type of investigation: 4110 - lens work order search: no similar complaint type events reported for units within the same lot.Claim#: (b)(4).

• Brand Name: IMPLANTABLE COLLAMER LENS (ICL)
• Common Device Name: PHAKIC 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: 19072902
• Report Number: 2023826-2024-01703
• Device Sequence Number: 4798515
• Product Code: MTA
• UDI-Device Identifier: 00840311300792
• UDI-Public: 00840311300792
• Combination Product (Y/N): N
• Initial Reporter Country: SN
• PMA/510(K) Number: P030016
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/15/2024

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: 08/31/2026
• Device Model Number: VICM5 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: 03/15/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/09/2024
• Supplement Report FDA Received Date: 04/19/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/15/2023
• 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 Age: 33 YR
• Patient Sex: Male