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	Intraocular Pressure Increased (1937)
Date of Event	02/10/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
The reporter indicated that the surgeon implanted a implantable collamer lens into the patient's eye.Baseline iop was 13-15 and after 6months baseline iop is around 22-24.Eye drops prescribed.Additional information has been requested but none has been forthcoming.
Additional Manufacturer Narrative
D2 - product code: unk (esubmitter software does not allow for a blank or 'unk' entry).(b)(4).
Additional Manufacturer Narrative
Additional information place through out form.Claim# (b)(4).
Event or Problem Description
The reporter indicated that the surgeon implanted a 13.2mm vicm5_13.2, -04.50 diopter, implantable collamer lens into the patient's right eye (od) on (b)(6) 2023.Eye drops (smbrinza tid) prescribed for elevated iop 27mmhg without pupil block and angle closure(assessed on (b)(6) 2023).Problem resolved.Cause of event reported as unknown.
Additional Manufacturer Narrative
Correction information: d4 - reported as - serial # (b)(6) - correct to - serial # (b)(6).H4 - reported as - 01-nov-2022 - correct to - 04-nov-2022.H6 - work order search: no similar complaint type events were 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
• MDR Report Key: 19509346
• Report Number: 2023826-2024-02535
• Device Sequence Number: 7424258
• Product Code: MTA
• UDI-Device Identifier: 00841542119306
• UDI-Public: 00841542119306
• 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
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/21/2024

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: 09/30/2024
• 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: 05/21/2024
• Supplement Date Received by Manufacturer: 06/05/2024; 09/13/2024
• Initial Report FDA Received Date: 06/11/2024
• Supplement Report FDA Received Date: 06/13/2024; 09/13/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/01/2022
• 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#UNK; FOAMTIPPLUNGER MODEL#FTP,LOT#UNK; INJECTOR MODEL#LIOLI-24, LOT#UNK
• Outcome Attributed to Adverse Event: Other
• Patient Age: 30 YR
• Patient Sex: Male