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

Model Number	TMICL13.2
Medical Device Problem Codes	Misfocusing (1401); Inadequacy of Device Shape and/or Size (1583)
Health Effect - Clinical Codes	Headache (1880); Blurred Vision (2137)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Sex, weight, ethnicity, race-unk.Date of event-unk.Claim# (b)(4).
Event or Problem Description
The reporter indicated that a 13.2mm tmicl13.2 implantable collamer lens, -12.0/+2.5/091 (sphere/cylinder/axis) was implanted into the patient's right (od) eye.The surgeon reports 300% vault, unexpected refractive outcome, and headache.
Additional Manufacturer Narrative
H3: device evaluation: the lens was returned with liquid in a vial.Visual inspection found no visible damage to the lens.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, -12.0/+2.5/091 (sphere/cylinder/axis) was implanted into the patient's right (od) eye.The lens was explanted on an unknown date.The surgeon reports 300% vault, unexpected refractive outcome, and headache.H6: 4627 - device explantation.Claim#: (b)(4).
Additional Manufacturer Narrative
H6 - type of investigation 3331 - device history record (dhr) review: based on the results of the investigation, all released devices from the associated work order(s), including the suspected device, have been manufactured within established process parameters and there is no indication that the manufacturing and processing of the device contributed to the complaint issue.H3 - device evaluation: the lens was returned with liquid in a vial.Visual inspection found no visible damage to the lens.Dimensional inspection found the lens to be wtithin specifications.The functional inspection found the lens to be out of specifications; the cylinder was out of tolerance by 0.26d.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: 12257217
• Report Number: 2023826-2021-02957
• Device Sequence Number: 4689719
• Product Code: QCB
• UDI-Device Identifier: 00841542109321
• UDI-Public: 00841542109321
• 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,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: 06/30/2022
• 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; 12/13/2021
• Initial Report FDA Received Date: 07/31/2021
• Supplement Report FDA Received Date: 12/09/2021; 02/14/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/05/2020
• 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