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

Model Number	TMICL 12.6
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/19/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
The reporter indicated that a 12.6mm tmicl 12.6 implantable collamer lens of -13.0/3.0/058 (sphere/cylinder/axis) was implanted into the patients right eye (od) on (b)(6) 2022.Lens rotation not associated to low vault was observed.Lens rotated 90 degrees.On (b)(6) 2022 the lens was removed and on same day different surgery a spherical lens was implanted of longer length and the problem resolved.Patient will require lasik surgery to address the astigmatism.
Additional Manufacturer Narrative
(b)(4).
Additional Manufacturer Narrative
H3: device evaluation - lens was returned in stuck in tape dry.Visual inspection found haptic torn and tape residue throughout the lens.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: 15686866
• Report Number: 2023826-2022-03577
• Device Sequence Number: 20509993
• Product Code: QCB
• UDI-Device Identifier: 00841542107303
• UDI-Public: 00841542107303
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: P030016
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/27/2022

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: 07/31/2024
• Device Model Number: TMICL 12.6
• 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: 09/27/2022
• Supplement Date Received by Manufacturer: 12/16/2022
• Initial Report FDA Received Date: 10/27/2022
• Supplement Report FDA Received Date: 12/21/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/10/2022
• 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.; FOAM TIP PLUNGER (FTP), LOT# UNK.; INJECTOR MODEL: MSI-PF, LOT# UNK.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 43 YR
• Patient Sex: Male