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

Model Number	TMICL12.6
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/30/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Claim # (b)(4).
Event or Problem Description
The reporter indicated the surgeon implanted a 12.6mm tmicl12.6 implantable collamer lens, -16.50/+1.5/092 (sphere/cylinder/axis), in the patients left eye (os) on (b)(6) 2022.The lens was explanted on (b)(6) 2022 due to lens rotation not associated to a low vault.The lens was replaced with another same model/length lens and the problem was resolved.The cause of the event was unknown.
Additional Manufacturer Narrative
Corrected data: b5- "the lens was replaced with a same model/ length lens and the problem was resolved" should be corrected to "the lens was replaced with a different model/ same length lens and the problem was resolved." claim# (b)(4).
Additional Manufacturer Narrative
Additional information: b5- "the reporter indicated the surgeon implanted a 12.6mm tmicl 12.6 implantable collamer lens of diopter -16.50/1.5/092 (sphere/cylinder/axis) into the patient's left eye (os) on (b)(6) 2022.The patient experienced lens rotation not associated to a low vault.On (b)(6) 2022 the lens was exchanged with a different model/ same length lens and the problem was not resolved.The cause of the event was unknown." 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: 15108454
• Report Number: 2023826-2022-02417
• Device Sequence Number: 11815535
• Product Code: QCB
• UDI-Device Identifier: 00841542107761
• UDI-Public: 00841542107761
• 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): 06/28/2022

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: 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: 06/28/2022
• Supplement Date Received by Manufacturer: 10/19/2022; 08/01/2023
• Initial Report FDA Received Date: 07/26/2022
• Supplement Report FDA Received Date: 10/19/2022; 08/03/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/10/2022
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 31 YR
• Patient Sex: Female