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

Model Number	TMICL13.2
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	06/16/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Health effect clinical code: (b)(4) (dissatisfaction with vision).Claim# (b)(4).
Event or Problem Description
The reporter indicated that the surgeon implanted a 13.2mm tmicl13.2 implantable collamer lens, -9.5/+3.5/094 (sphere/cylinder/axis) into the patient's left eye (os) on (b)(6) 2021.The surgeon reports possible lens rotation or misalignment and the patient is not satisfied with vision.Reportedly, the lens remains implanted.
Additional Manufacturer Narrative
H6-investigation code 4110: lens work order search-no similar complaints reported for units within the same lot.Claim# (b)(4).
Additional Manufacturer Narrative
B5: patient had pre-existing dry eye.A lens repositioning was performed on (b)(6) 2021.This did not resolved the problem.Reportedly; patient not satisfied with vision.Claim#: (b)(4).
Additional Manufacturer Narrative
B5 - patient reported they are unable to wear glasses because they cause headaches due to pressure on the sides of their head.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: 12322374
• Report Number: 2023826-2021-03119
• Device Sequence Number: 4002296
• Product Code: QCB
• UDI-Device Identifier: 00841542108997
• UDI-Public: 00841542108997
• Combination Product (Y/N): N
• Initial Reporter State: UT
• Initial Reporter Country: US
• PMA/510(K) Number: P030016
• 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: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 07/22/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 10/31/2022
• 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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/22/2021
• Supplement Date Received by Manufacturer: 09/29/2021; 02/27/2022; 05/24/2022
• Initial Report FDA Received Date: 08/15/2021
• Supplement Report FDA Received Date: 10/08/2021; 02/27/2022; 06/03/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/11/2020
• 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.
• Patient Age: 43 YR
• Patient Sex: Female