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

Model Number	TMICL13.2
Medical Device Problem Code	Inadequacy of Device Shape and/or Size (1583)
Health Effect - Clinical Code	Headache (1880)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Pt info: unk.Date of event-unk.Lens work order search-no similar complaint type events reported for units within the same lot.Claim# (b)(4).
Event or Problem Description
The reporter indicated that a 13.2mm tmicl13.2 implantable collamer lens, -9.0/+3.0/089 (sphere/cylinder/axis) was implanted into the patient's left (os) eye.The surgeon reports 200% vault and headache.
Additional Manufacturer Narrative
H3: device evaluation: the lens was returned with liquid in a vial.Visual inspection found the optic torn and haptic torn.Unable to perform a dimensional and functional verification since lens has significant damage.Additional information: b1: changed to adverse event.B2: changed to - required intervention to prevent permanent/impairment damage.B5: the reporter indicated that a 13.2mm tmicl13.2 implantable collamer lens, -9.0/+3.0/089 (sphere/cylinder/axis) was implanted into the patient's left (os) eye.The lens was explanted on an unknown date.The surgeon reports 200% vault, headache, and refractive surprise.H6: 4627 - device explantation.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: 12257229
• Report Number: 2023826-2021-02956
• Device Sequence Number: 19957025
• Product Code: QCB
• UDI-Device Identifier: 00841542108911
• UDI-Public: 00841542108911
• Combination Product (Y/N): N
• Initial Reporter State: CO
• 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): 07/06/2021

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: 10/31/2022
• Device Model Number: TMICL13.2
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/12/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/06/2021
• Supplement Date Received by Manufacturer: 11/10/2021
• Initial Report FDA Received Date: 07/31/2021
• Supplement Report FDA Received Date: 12/09/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/10/2020
• 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: Unknown