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

Model Number	TMICL12.6
Medical Device Problem Codes	Device Dislodged or Dislocated (2923); Optical Problem (3001)
Health Effect - Clinical Codes	Cataract (1766); Visual Disturbances (2140); Halo (2227); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Type of Reportable Event	Serious Injury
Event or Problem Description
The reporter indicated that a 12.6mm, tmicl12.6, -12.5/2.5/097 (sphere/cylinder/axis), implantable collamer lens was implanted into the patient's right eye (od) on (b)(6) 2022.Lens repositioning on (b)(6) 2022 was performed due to rotation and disphotopsia issues but did not resolve the problem.The lens was exchanged for a longer length similar power lens (sphere/cylinder/axis) on (b)(6) 2023.Problem resolved.
Additional Manufacturer Narrative
H6- health effect impact code 4581: disphotopsia issues.H6 - work order search: no similar complaint type events were reported for units within the same lot.Claim#(b)(4).
Additional Manufacturer Narrative
Additional information: a2 - (b)(6) 1983, a3 - m, b3 - 13-sep-2022.Correction: b5 - reported as: the reporter indicated that a 12.6mm, tmicl12.6, -12.5/2.5/097 (sphere/cylinder/axis), implantable collamer lens was implanted into the patient's right eye (od) on (b)(6) 2022.Lens repositioning on (b)(6) 2022 was performed due to rotation and disphotopsia issues but did not resolve the problem.The lens was exchanged for a longer length similar power lens (sphere/cylinder/axis) on (b)(6) 2023.Problem resolved.Correct to: the reporter indicated that a 12.6mm, tmicl12.6, -12.5/2.5/097 (sphere/cylinder/axis), implantable collamer lens was implanted into the patient's right eye (od) on (b)(6) 2022.Lens repositioning on (b)(6) 2022 was performed due to rotation and glare/haloes but did not resolve the problem.The lens was explanted on (b)(6) 2023 and in as second surgery on (b)(6) 2023 a longer length similar power lens (sphere/cylinder/axis) was implanted.Problem resolved.Reportedly, mild asc and patient is very happy.Claim# (b)(4).
Additional Manufacturer Narrative
Corrected data: b5- the reporter indicated that the surgeon implanted a 12.6mm tmicl 12.6 implantable collamer lens of diopter -12.50/2.5/097 (sphere/cylinder/axis) into the patient's right eye (od) on (b)(6) 2022.The patient experienced lens rotation not associated with low vault, lens repositioning, glares/haloes and a lens opacity was observed.On (b)(6) 2022 the lens was repositioned but that did not resolve the problem.On (b)(6) 2022 the lens was explanted.On the same day separate surgery a longer length lens was implanted and the problem was resolved.Status of eye: "mild asc.Pt very happy".The reporter indicated the cause of the event is unknown.Cause details provided: "rotation- lens too small".H6-health effect - clinical code: "4581: disphotopsia issues" should be removed and "1766" should be added.H6-health effect - impact code: "4629" should be removed and "4627" should be added.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: joselene muniz ; 1911 walker avenue; monrovia, CA 91016
• MDR Report Key: 17844162
• Report Number: 2023826-2023-04346
• Device Sequence Number: 7173851
• Product Code: QCB
• UDI-Device Identifier: 00841542107228
• UDI-Public: 00841542107228
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: N/A
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2023
• 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,Followup
• Report Date (Section B): 09/06/2023

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
• 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: 09/06/2023
• Supplement Date Received by Manufacturer: 10/05/2023; 01/09/2024
• Initial Report FDA Received Date: 09/29/2023
• Supplement Report FDA Received Date: 10/06/2023; 01/09/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/03/2021
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown