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

Model Number	TMICL13.2
Medical Device Problem Codes	Inadequacy of Device Shape and/or Size (1583); Adverse Event Without Identified Device or Use Problem (2993)
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 13.2mm vticm513.2 implantable collamer lens of -9.5/1.0/093 (sphere/cylinder/axis) was implanted into the patient's eye.Low vault was observed.
Additional Manufacturer Narrative
Work order search found no similar complaints.(b)(4).
Additional Manufacturer Narrative
B5- the reporter indicated that the surgeon implanted a 13.2mm tmicl 13.2 implantable collamer lens of diopter -10.00/1.0/089 (sphere/cylinder/axis) into the patient's eye.The patient experienced a low vault.The lens was explanted.H6- remove "health effect - impact code: 2199" claim\# (b)(4).
Additional Manufacturer Narrative
Corrected data: b5 a 13.2mm tmicl13.2 implantable collamer lens of a -10.0/1.0/089 (sphere/cylinder/axis) was implanted into the patient's eye.H3: device evaluation: product was returned with liquid in a vial.Visual inspection found no visible damage to the lens.H6: work order search found no similar complaints.Claim#: (b)(4).
Additional Manufacturer Narrative
Corrected data: b5- the reporter indicated that the surgeon implanted a 13.2mm tmicl 13.2 implantable collamer lens of diopter -10.00/1.0/089 (sphere/cylinder/axis) into the patient's left eye (os) on (b)(6) 2020.The lens was explanted.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: 16110233
• Report Number: 2023826-2023-00047
• Device Sequence Number: 5753581
• Product Code: QCB
• UDI-Device Identifier: 00841542109017
• UDI-Public: 00841542109017
• Combination Product (Y/N): N
• Initial Reporter State: OK
• Initial Reporter Country: US
• PMA/510(K) Number: P030016
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• 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,Followup
• Report Date (Section B): 12/06/2022

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: 03/31/2022
• Device Model Number: TMICL13.2
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/06/2022
• Supplement Date Received by Manufacturer: 01/17/2023; 05/03/2023; 06/08/2023
• Initial Report FDA Received Date: 01/05/2023
• Supplement Report FDA Received Date: 02/08/2023; 05/03/2023; 06/09/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/07/2020
• 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