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

Model Number	VTICM5 13.2
Medical Device Problem Code	Misfocusing (1401)
Health Effect - Clinical Code	Blurred Vision (2137)
Date of Event	04/11/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
The reporter indicated that an implantable collamer lens was implanted into the patient's left eye (os).The patient experienced refractive surprise, lens remains implanted.Attempts to obtain additional information have not been successful.If additional information is received a supplemental medwatch report will be submitted.
Additional Manufacturer Narrative
Claim#: (b)(4).
Additional Manufacturer Narrative
B5 - the reporter indicated that a 13.2mm vticm5_13.2 -13.50/1.5/062 (sphere/cylinder/axis) was implanted into the patient's left eye (os) on (b)(6) 2023.Refractive surprise was observed.Lens remains implanted.Cause is reported as unknown.Claim# (b)(4).
Additional Manufacturer Narrative
H6 - investigation type 4110: lens work order search - no similar complaint event(s) within associated lots were found.Claim# (b)(4).
Additional Manufacturer Narrative
B5: it was later reported that the patient got laser touch up on (b)(6) 2023.The problem was resolved.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: 17218627
• Report Number: 2023826-2023-02556
• Device Sequence Number: 6224052
• Product Code: MTA
• UDI-Device Identifier: 00840311311538
• UDI-Public: 00840311311538
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 05/30/2023

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: 01/31/2026
• 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: 05/30/2023
• Supplement Date Received by Manufacturer: 12/13/2023; 12/13/2023; 03/06/2024
• Initial Report FDA Received Date: 06/28/2023
• Supplement Report FDA Received Date: 12/13/2023; 12/13/2023; 03/18/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/28/2023
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 38 YR
• Patient Sex: Female