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	Fatigue (1849); Headache (1880); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	02/28/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Health effect clinical code: 4581 hyperopic/showing cyl.Type of investigation: 4110 lens work order search: no similar complaint type events reported for units within the same lot.(b)(4).
Event or Problem Description
The reporter indicated that the surgeon implanted a 12.6mm vticm5_12.6; -6.5/2.5/102 (sphere/cylinder/axis) implantable collamer lens into the patient's left eye (os) on (b)(6) 2023.The surgeon reports the patient is hyperopic and showing residual cyl; has headaches and fatigue; steroids were prescribed.Lens remains implanted.If additional information is received a supplemental medwatch report will be submitted.
Additional Manufacturer Narrative
Additional information: b5: the reporter indicated that the surgeon implanted a 12.6mm vticm5_12.6; -6.5/2.5/102 (sphere/cylinder/axis) implantable collamer lens into the patient's left eye (os) on (b)(6)2023.The surgeon reports the patient is hyperopic and showing residual cyl; has headaches and fatigue; steroids were prescribed.Reportedly, the lens was exchanged on (b)(6) 2023 for a same model and same length but different diopter lens.It has not been reported if the problem resolved.Claim# (b)(4).
Additional Manufacturer Narrative
Corrected data: d6a: should be corrected to 09-feb-2023.H6: 4629 should be corrected to 4627.Additional information: b5: the reporter indicated that the surgeon implanted a 12.6mm vticm5_12.6; -6.5/2.5/102 (sphere/cylinder/axis) implantable collamer lens into the patient's left eye (os) on (b)(6)2023.The surgeon reports the patient is hyperopic and showing residual cyl; has headaches and fatigue; steroids were prescribed.Reportedly, the lens was exchanged on (b)(6) 2023 for a same model and same length but different diopter lens.It is unclear whether lens removal and replacement occurred intraoperatively.Residual cylinder was present after the exchange.It has not been reported if the problem resolved.Claim# (b)(4).
Additional Manufacturer Narrative
Additional information: d9: return date: 25-aug-2023.H3 - device evaluation: the lens was returned in liquid in a vial.Visual inspection found the lens haptic torn and fiber on the lens.Dimensional and functional inspection found the lens to be within specifications.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 SUGICAL COMPANY; 1911 walker avenue; monrovia CA 91016
• Manufacturer Contact: joselene enriquez ; 1911 walker avenue; monrovia, CA 91016
• MDR Report Key: 16622823
• Report Number: 2023826-2023-01088
• Device Sequence Number: 5577460
• Product Code: QCB
• UDI-Device Identifier: 00841542114509
• UDI-Public: 00841542114509
• Combination Product (Y/N): N
• Initial Reporter State: OK
• Initial Reporter Country: US
• 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: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 02/28/2023

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: 08/31/2024
• Device Model Number: VTICM5_12.6
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/28/2023
• Supplement Date Received by Manufacturer: 05/26/2023; 06/27/2023; 01/08/2024
• Initial Report FDA Received Date: 03/27/2023
• Supplement Report FDA Received Date: 06/22/2023; 07/13/2023; 01/24/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/07/2022
• 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, LOT#-1589913.; FOAM TIP PLUNGER MODEL-FTP, LOT#-1590141.; INJECTOR MODEL-MSI-PF, LOT#-UNK.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 36 YR
• Patient Sex: Female