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
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).
Event or Problem Description
The reporter indicated that a 12.6mm, tmicl12.6, -12.5/2.5/092 (sphere/cylinder/axis), implantable collamer lens was implanted into the patient's left eye (os) on (b)(6) 2022.Lens was exchanged with longer length similar power lens(sphere/cylinder/axis) due to disphotopsia issues on (b)(6) 2023.Problem resolved.
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, -12.5/2.5/092 (sphere/cylinder/axis), implantable collamer lens was implanted into the patient's left eye (os) on (b)(6) 2022.Lens was exchanged with longer length similar power lens(sphere/cylinder/axis) due to disphotopsia issues on (b)(6) 2023.Problem resolved.Correct to: the reporter indicated that a 12.6mm, tmicl12.6, -12.5/2.5/092 (sphere/cylinder/axis), implantable collamer lens was implanted into the patient's left eye (os) on (b)(6) 2022.Lens was explanted and a new longer length similar power lens(sphere/cylinder/axis) was later implanted due to lens rotation not associated to low vault and glare/haloes on (b)(6) 2023.Problem resolved.Reportedly mild asc, 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 -12.00/2.0/092 (sphere/cylinder/axis) into the patient's left eye (os) on (b)(6) 2022.The patient experienced lens rotation not associated with low vault, glares/halos, and a lens opacity was observed.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 'other'.Cause details provided: "size probably 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: 17844244
• Report Number: 2023826-2023-04347
• Device Sequence Number: 4320747
• Product Code: QCB
• UDI-Device Identifier: 00841542107143
• UDI-Public: 00841542107143
• 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: 04/30/2023
• 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: 05/12/2021
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown