MAUDE Adverse Event Report: STAAR SURGICAL COMPANY IMPLANTABLE COLLAMER LENS

Model Number	TMICL12.6
Medical Device Problem Codes	Misfocusing (1401); Inadequacy of Device Shape and/or Size (1583); Device Dislodged or Dislocated (2923)
Health Effect - Clinical Codes	Blurred Vision (2137); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/19/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
The reporter states an implantable collamer lens was implanted into the patient's right (od) eye.The surgeon reports an oversized icl.Attempts to obtain additional information have not been successful.
Additional Manufacturer Narrative
B1 - corrected to adverse event in initial mdr.B2 - corrected to required intervention to prevent impairment/damage (devices) in initial mdr.B3 - date of event (b)(6) 2022 should be added to the initial mdr.B5 - "the reporter indicated the surgeon implanted a 12.6mm tmicl 12.6 implantable collamer lens, -17.00/2.0/089 (sphere/cylinder/axis), in the patients right eye (od) on (b)(6) 2022.The lens was explanted on (b)(6) 2022 due low vault with rotation, lens "dislocation"/subluxation, and blurred vision.The lens was replaced with another same model/ longer length lens and the problem was resolved.The reporter marked the cause of the event as the device." should be added to the initial mdr.D6a - implant date (b)(6) 2022 should be added to initial mdr.D6b - explant date (b)(6) 2022 should be added to initial mdr.H1 - corrected to serious injury in initial mdr.H6 - health effect - impact code: 4627 should be added to initial mdr.H6 - health effect - clinical code: 2137 should be added to initial mdr.H6 - health effect - device code: 1401 -2923 should be added to initial mdr.H6 - health effect - type if investigation code: 4110-41111 :" lens work order search - no similar complaints reported for units within the same lot." should be added to initial mdr.Claim #: (b)(4).

• Brand Name: IMPLANTABLE COLLAMER LENS
• Common Device Name: UNK
• 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: 14402698
• Report Number: 2023826-2022-01529
• Device Sequence Number: 5606807
• Product Code: MTA
• UDI-Device Identifier: 00841542107846
• UDI-Public: 00841542107846
• Combination Product (Y/N): N
• Initial Reporter State: NV
• 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,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/18/2022

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?: Yes
• Operator of Device: Health Professional
• 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: 04/18/2022
• Supplement Date Received by Manufacturer: 06/27/2022
• Initial Report FDA Received Date: 05/13/2022
• Supplement Report FDA Received Date: 06/28/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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 Sex: Unknown