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

Model Number	TMICL12.6
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/27/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
The reporter indicated that the surgeon implanted a 12.6mm tmicl12.6 implantable collamer lens, -12.5/+2.0/072 (sphere/cylinder/axis) into the patient's left (os) eye on (b)(6) 2021.On (b)(6) 2021 the lens was repositioned due to lens rotation.On (b)(6) 2021 the lens was exchanged with a longer lens due to lens rotation.The problem is resolved.The cause of the event is reported as unknown.
Additional Manufacturer Narrative
Weight, race, ethnicity:unk.Claim# (b)(4).
Additional Manufacturer Narrative
H3: device evaluation - lens was returned in vial dry with residue on product.Visual inspection found haptic torn.Dimensional inspection found the lens to be within specification.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 ; 8002927902
• MDR Report Key: 12973362
• Report Number: 2023826-2021-04696
• Device Sequence Number: 14631446
• Product Code: QCB
• UDI-Device Identifier: 00841542107211
• UDI-Public: 00841542107211
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: P030016
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2021
• 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
• Report Date (Section B): 11/11/2021

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 10/31/2022
• Device Model Number: TMICL12.6
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/11/2021
• Supplement Date Received by Manufacturer: 05/03/2023
• Initial Report FDA Received Date: 12/09/2021
• Supplement Report FDA Received Date: 10/11/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/17/2020
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 41 YR
• Patient Sex: Male