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

Model Number	TMICL12.1
Medical Device Problem Codes	Inadequacy of Device Shape and/or Size (1583); Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Sex, weight, ethnicity - unk.Date of event - unk.(b)(4).Claim# (b)(4).
Event or Problem Description
The reporter states a 12.1mm tmicl12.1 implantable collamer lens -10.5/+3.0/090 (sphere/cylinder/axis) was implanted into the patient's left (os) eye on (b)(6) 2021.The surgeon reports the lens is too small and keeps rotating.Reportedly the lens remains implanted.
Additional Manufacturer Narrative
B5- the reporter states a 12.1mm tmicl12.1 implantable collamer lens -10.5/+3.0/090 (sphere/cylinder/axis) was implanted into the patient's left (os) eye on (b)(6) 2021.The lens was explanted on an unknown date.D6b- unk.H3- device evaluation: the lens was returned in a vial with liquid.Visual inspection found the optic and haptic torn.Claim# (b)(4).

• Brand Name: IMPLANTABLE COLLAMER LENS
• 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: cynthia thai ; 1911 walker avenue; monrovia, CA 91016 ; 8002927902
• MDR Report Key: 12426106
• Report Number: 2023826-2021-03445
• Device Sequence Number: 17038205
• Product Code: QCB
• UDI-Device Identifier: 00841542104784
• UDI-Public: 00841542104784
• Combination Product (Y/N): N
• Initial Reporter State: UT
• Initial Reporter Country: US
• PMA/510(K) Number: P030016
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• 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): 08/13/2021

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 Expiration Date: 04/30/2022
• Device Model Number: TMICL12.1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/20/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/13/2021
• Supplement Date Received by Manufacturer: 02/25/2022
• Initial Report FDA Received Date: 09/03/2021
• Supplement Report FDA Received Date: 03/01/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/22/2020
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown