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

Model Number	TMICL13.2
Medical Device Problem Codes	Misfocusing (1401); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Cataract (1766); Blurred Vision (2137); No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A4 - unk, a5 - unk, a6 - unk, b3 - unk, d6a - unk.Claim# (b)(4).
Event or Problem Description
The reporter indicated that a 13.2mm, tmicl13.2, -11.0/1.0/075 (sphere/cylinder/axis), implantable collamer lens was implanted into the patient's left eye (os).Lens opacity (cataract) asc was observed on (b)(6) 2023.Lens remains implanted.Reportedly, patient is trailing a scl for the refractive shift and will refer cataract surgery for now.
Additional Manufacturer Narrative
Corrected data: h6- health effect - clinical code: "1766" and "2137" should be added.H6- health effect - impact code: "2199" should be removed."4614 " should be added.H6- medical device problem code: "2993" should be removed."1401" should be added.B5- the reporter indicated that the surgeon implanted a 13.2mm tmicl 13.2 implantable collamer lens of diopter -13.00/1.5/092 (sphere/cylinder/axis) into the patient's left eye (os).The patient experienced an asc lens opacity observed on 17/may/2023, refractive change over time, and a spherical contact lens prescribed.The lens remains implanted.Status of the eye:" patient is trialing scl (spherical contact lens) os for the refractive shift; will defer cataract surgery for now." 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: 17610615
• Report Number: 2023826-2023-03705
• Device Sequence Number: 6712631
• Product Code: QCB
• UDI-Device Identifier: 00841542109444
• UDI-Public: 00841542109444
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: P030016
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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
• Report Date (Section B): 08/23/2023

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: 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: 08/23/2023
• Supplement Date Received by Manufacturer: 10/23/2023
• Initial Report FDA Received Date: 08/24/2023
• Supplement Report FDA Received Date: 10/30/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/05/2020
• 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: UNK.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Female