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

Model Number	TMICL13.2
Medical Device Problem Code	Inadequacy of Device Shape and/or Size (1583)
Health Effect - Clinical Code	Intraocular Pressure Increased (1937)
Date of Event	06/24/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Type of investigation: lens work order search: no similar complaint type events reported for units within the same lot.Claim#: (b)(4).
Event or Problem Description
The reporter indicated that the surgeon implanted a 13.2mm tmicl13.2; -17.0/2.5/076 (sphere/cylinder/axis) implantable collamer lens into the patient's left eye (os) on (b)(6)2021.The surgeon reports excessive vaulting and elevated intraocular pressure and noted "excessive vaulting causing angles to narrow".Lens remains implanted.The cause of the event was reported as the device.
Additional Manufacturer Narrative
Additional information: b5: it was later reported that on (b)(6) 2021 the patient was seen for an evaluation, patient had high vaulting but normal iop on hypotensive medication and was instructed to discontinue medication.Then on (b)(6) 2021, another evaluation was performed and the patient had increased iop off medication and a decision was made to repeat/enlarge lpis to assess if any improvement in iop.It was also indicated if no improvement with iop occurs a lens exchange is planned.H6 - health effect impact code: 4625 additional surgery - lpi repeat/enlarge.Claim#: (b)(4).
Additional Manufacturer Narrative
Additional information: b5 - it was later reported that the patient's diurnal iop measurement and iop is within normal limits/stable after repeat lpi and off hypotensive medications, and they would not be proceeding with a lens exchange.Patient will continued being monitored.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 SURGICAL COMPANY; 1911 walker avenue; monrovia CA 91016
• Manufacturer Contact: cynthia thai ; 1911 walker avenue; monrovia, CA 91016 ; 6263037902
• MDR Report Key: 12204759
• Report Number: 2023826-2021-02558
• Device Sequence Number: 17200009
• Product Code: QCB
• UDI-Device Identifier: 00841542110020
• UDI-Public: 00841542110020
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/12/2021

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: 04/30/2023
• Device Model Number: TMICL13.2
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Received by Manufacturer: 07/12/2021
• Supplement Date Received by Manufacturer: 08/24/2021; 11/12/2021
• Initial Report FDA Received Date: 07/21/2021
• Supplement Report FDA Received Date: 08/26/2021; 11/15/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/13/2021
• 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.; FOAM TIP PLUNGER MODEL-FTP, LOT#-UNK.; CARTRIDGE MODEL-SFC-45, LOT#-UNK; FOAM TIP PLUNGER MODEL-FTP, LOT#-UNK
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 27 YR
• Patient Sex: Female