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

Model Number	VTICM5_13.6
Medical Device Problem Code	Misfocusing (1401)
Health Effect - Clinical Code	Blurred Vision (2137)
Date of Event	06/02/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Claim# (b)(4).
Event or Problem Description
The reporter indicated that the surgeon implanted an implantable collamer lens into the patient's eye.The surgeon reports there is refractive surprise in a patient who had surgery in late march/early (b)(6) 2023.Lens remains implanted.If additional information is received a supplemental medwatch report will be submitted.
Additional Manufacturer Narrative
H7 - recall.H9 - 2023826-10/16/2023-001-r.Claim #: (b)(4).
Additional Manufacturer Narrative
Additional information: b5 - it was later reported that the surgeon implanted a 13.7mm vticm5_13.7; -9.5/2.5/85 (sphere/cylinder/axis) implantable collamer lens was implanted into the patient's right eye (od) on (b)(6) 2023.The patient experienced refractive surprise.The surgeon performed lasik surgery to reduce remaining cylinder post icl and this resolved the problem.The cause of the event was reported as a patient related factor.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 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 muniz ; 1911 walker avenue; monrovia, CA 91016
• MDR Report Key: 18166188
• Report Number: 2023826-2023-05169
• Device Sequence Number: 5541157
• Product Code: QCB
• UDI-Device Identifier: 00841542118149
• UDI-Public: 00841542118149
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• 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: Health Professional
• Initial Reporter Occupation: Physician
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/26/2023
• 2 Devices were Involved in the Event: 1 2

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: 11/30/2024
• Device Model Number: VTICM5_13.6
• 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: 10/26/2023
• Supplement Date Received by Manufacturer: 11/21/2023; 02/14/2024
• Initial Report FDA Received Date: 11/17/2023
• Supplement Report FDA Received Date: 11/22/2023; 02/14/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/08/2023
• 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
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: 2023826-10/16/2023-001-R
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 34 YR
• Patient Sex: Male