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

Model Number	TMICL12.6
Medical Device Problem Code	No Apparent Adverse Event (3189)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Serious Injury
Event or Problem Description
The reporter indicated that a 12.6mm tmicl12.6 implantable collamer lens with a -15.0/3.5/090 (sphere/cyclinder/axis) was implanted into the patient's eye.The lens was removed and replaced for a vticmo lens.Reportedly, "the first lens was kinked and affected the outcome of patient's vision so we had to exchange the lens.".
Additional Manufacturer Narrative
Work order search found no similar complaints.Claim# (b)(4).
Additional Manufacturer Narrative
Corrected data: d6a.- "(b)(6) 2022." b5- "the reporter indicated that the surgeon implanted a 12.6mm tmicl 12.6 implantable collamer lens of diopter -15.00/3.5/090 (sphere/cylinder/axis) into the patient's eye in (b)(6) 2022.Reportedly "the first lens was kinked and affected the outcome of patient's vision so we had to exchange the lens".The lens was explanted and replaced with a different model/ same length and the problem was resolved." claim# (b)(4).
Additional Manufacturer Narrative
Device evaluation: h3: device evaluation: the lens was returned in a vial with liquid.Visual inspection found no visible damage.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 SUGICAL COMPANY; 1911 walker avenue; monrovia CA 91016
• Manufacturer Contact: joselene enriquez ; 1911 walker avenue; monrovia, CA 91016 ; 8002927902
• MDR Report Key: 16134902
• Report Number: 2023826-2023-00055
• Device Sequence Number: 20472828
• Product Code: QCB
• UDI-Device Identifier: 00841542107594
• UDI-Public: 00841542107594
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/12/2022

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
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/10/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/12/2022
• Supplement Date Received by Manufacturer: 02/24/2023; 02/27/2023
• Initial Report FDA Received Date: 01/10/2023
• Supplement Report FDA Received Date: 02/24/2023; 02/27/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/15/2021
• 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
• Concomitant Medical Products and Therapy/Usage Dates: UNK.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown