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

Model Number	TMICL12.6
Medical Device Problem Codes	Misfocusing (1401); Device Dislodged or Dislocated (2923)
Health Effect - Clinical Codes	Blurred Vision (2137); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581); No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Serious Injury
Event or Problem Description
The reporter indicated the surgeon implanted a 12.6mm tmicl12.6 implantable collamer lens, -13.00/+2.5/179 (sphere/cylinder/axis), in the patients left eye (os) on (b)(6) 2022.The lens was removed on (b)(6) 2022 due to lens rotation not associated to a low vault.The lens was replaced with a longer lens and the problem was resolved.The cause of the event was unknown.Post-op, the patient's va was blurry, see mfr.Report # 2023826-2023-00569 for replacement lens.The patient had intacs implanted and was using artificial tears.
Additional Manufacturer Narrative
Patient weight, ethnicity & race unknown.Event date unknown.Adverse event problem work order search: no similar complaint was reported for units within the same lot.Claim # (b)(4).
Additional Manufacturer Narrative
B5: the lens was rotated (repositioned) despite normal vault.Patient's va was much blurrier at initial post-op, which is why the lens was removed and replaced with longer lens.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 -13.00/2.5/179 (sphere/cylinder/axis) into the patients left eye (os) on (b)(6) 2022.The patient experienced lens rotation not associated with a low vault, repositioning, blurred vision and intacs intracorneal rings.On (b)(6) 2022 the lens was repositioned and exchanged for a longer length lens and the problem was resolved.Status of the eye; "clear va and had adjusted to haze/shadow using artificial tears prn." additional information provided was "clear va at night, dilated exam shows intacs intact".The reporter indicated the cause of the event is unknown- " rotated visian icl despite normal vault.Explant and insertion of longer icl to help prevent rotation.Va much blurrier during post op".H6- health effect- clinical code: 4581-intacs intracorneal rings.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 enriquez ; 1911 walker avenue; monrovia, CA 91016
• MDR Report Key: 16411020
• Report Number: 2023826-2023-00568
• Device Sequence Number: 5362865
• Product Code: QCB
• UDI-Device Identifier: 00841542107297
• UDI-Public: 00841542107297
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: P030016
• 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,Followup
• Report Date (Section B): 01/27/2023

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: 01/31/2024
• 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: 01/27/2023
• Supplement Date Received by Manufacturer: 01/30/2023; 06/09/2023
• Initial Report FDA Received Date: 02/21/2023
• Supplement Report FDA Received Date: 05/10/2023; 06/09/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/28/2022
• 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: UNKNOWN.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Male