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

Model Number	TMICL 12.1
Medical Device Problem Codes	Misfocusing (1401); Unintended Movement (3026)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/10/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Date of event:unknown.Claim#: (b)(4).
Event or Problem Description
The reporter indicated that a 12.1mm tmicl 12.1 implantable collamer lens of -7.00/2.0/080 (sphere/cylinder/axis) was implanted into the patient's eye on (b)(6) 2022.On (b)(6) 2022 the lens was removed and replaced for spherical lens due to lens shifted in the eye.Attempts to obtain additional information have not been successful.If additional information is received a supplemental medwatch report will be submitted.
Additional Manufacturer Narrative
Date of event:unknown.Claim#: (b)(4).
Event or Problem Description
The reporter indicated that a 12.1mm tmicl 12.1 implantable collamer lens of -7.00/2.0/080 (sphere/cylinder/axis) was implanted into the patient's eye on (b)(6) 2022.On (b)(6) 2022 the lens was removed and replaced for spherical lens due to lens shifted in the eye.Attempts to obtain additional information have not been successful.If additional information is received a supplemental medwatch report will be submitted.
Additional Manufacturer Narrative
Corrected data: b5- the reporter indicated that a 12.1mm tmicl 12.1 implantable collamer lens of -7.00/2.0/080 (sphere/cylinder/axis) was implanted into the patient's eye on (b)(6) 2022.On 10-9b)(6) 2022 the lens was explanted and on the same day different surgery a replacement spherical lens was implanted.This was due to lens rotation and refractive change over time.The problem was resolved.Improved vision with residual astigmatism.Cause reported as a patient related factor.Additional information: h6-device evaluation: lens returned in a vial, dry with residue on prduct.Visual inspection found no visible damage to lens.Residue throughout the whole lens.Lens has an orange tint to it.Dimensional inspection found the lens to be within specifications.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: 13795938
• Report Number: 2023826-2022-00783
• Device Sequence Number: 19806350
• Product Code: QCB
• UDI-Device Identifier: 00841542104272
• UDI-Public: 00841542104272
• Combination Product (Y/N): N
• Initial Reporter State: OK
• Initial Reporter Country: US
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/14/2022

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: 02/28/2023
• Device Model Number: TMICL 12.1
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• 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: 02/14/2022
• Supplement Date Received by Manufacturer: 05/04/2022
• Initial Report FDA Received Date: 03/17/2022
• Supplement Report FDA Received Date: 07/01/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/12/2021
• 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 (FTP), LOT# UNK.; INJECTOR MODEL: MSI-PF, LOT# UNK.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 32 YR
• Patient Sex: Unknown