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

Model Number	TMICL12.6
Medical Device Problem Codes	Inadequacy of Device Shape and/or Size (1583); Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/01/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
The reporter indicated the surgeon implanted a 12.6mm tmicl12.6 implantable collamer lens, -11.00/+3.5/084 (sphere/cylinder/axis), in the patients left eye (os) on (b)(6) 2021.The lens was explanted on (b)(6) 2022 due to low vaulting and lens rotation.The lens was replaced with a longer lens and the problem was resolved.Post-op, there was no pain but mild inflammation.See mfr.Report # 2023826-2022-00428 for replacement lens.The cause of the event was due to the device.Additional information has been requested but none has been forthcoming.
Additional Manufacturer Narrative
Weight: unk.Race: unk.Ethnicity: unk.Claim # (b)(4).
Additional Manufacturer Narrative
Corrected data: b5: the reporter indicated the surgeon implanted a 12.6mm tmicl12.6 implantable collamer lens, -11.00/+3.5/084 (sphere/cylinder/axis), in the patient's left eye (os), on (b)(6) 2021.The lens was explanted on (b)(6) 2022 due to low vaulting and lens rotation.The lens was replaced wih a longer lens and the problem was resolved.Post-op, there was no pain but mild inflammation.The inflammation was mild cell and flare, which was mild and normal for the surgery, and has resolved.The cause of the event was due to the device.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: 13488916
• Report Number: 2023826-2022-00400
• Device Sequence Number: 12074077
• Product Code: QCB
• UDI-Device Identifier: 00841542107037
• UDI-Public: 00841542107037
• Combination Product (Y/N): N
• Initial Reporter State: CO
• 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: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/10/2022

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: 09/30/2023
• Device Model Number: TMICL12.6
• 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: 01/10/2022
• Supplement Date Received by Manufacturer: 02/09/2022
• Initial Report FDA Received Date: 02/08/2022
• Supplement Report FDA Received Date: 02/23/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/11/2021
• 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 # 1546174; FOAM TIP PLUNGER MODEL FTP - LOT # 1556534; INJECTOR MODEL MSI-PF - LOT # 1522339
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 30 YR
• Patient Sex: Male