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

Model Number	VTICM5_12.6
Medical Device Problem Codes	Off-Label Use (1494); Unintended Movement (3026); No Apparent Adverse Event (3189)
Health Effect - Clinical Codes	Visual Disturbances (2140); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/25/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Patient information- unk.Implant date, explant date-unk.No similar complaint type events reported for units within the same lot.Claim # (b)(4).
Event or Problem Description
The reporter states that a 12.6 mm vticm5_12.6 implantable collamer lens -8.0/+2.0/088 (sphere/cylinder/axis) was implanted into the patient's eye.Reportedly, the lens flipped and was removed.Attempts to obtain additional information have not been successful.
Additional Manufacturer Narrative
B5: the reporter stated that the surgeon implanted, removed and replaced intraoperatively a 12.6mm vicm5_12.6 -8.00/+2.0/088 (sphere/cylinder/axis) into the patient's right eye (od) on (b)(6) 2022 due to lens being implanted upside down.This resolved the problem.The status of eye is reported as " blurry vision at night, patient see haloes and glare at night." cause of the event is reported as "device".H6: device code: 1494: this lens model is contraindicated for patients with an anterior chamber depth (acd) less than 3.0mm.Claim# (b)(4).
Additional Manufacturer Narrative
B5: the reporter stated that the surgeon implanted and flipped a 12.6mm vicm5_12.6 -8.00/+2.0/088 (sphere/cylinder/axis) into the patient's right eye (od) on (b)(6) 2022 due to the lens being implanted upside down.On the same day but different surgery, the lens was exchanged and the problem was resolved.The status of eye is reported as " blurry vision at night, patient see haloes and glare at night." cause of the event is reported as "device".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: joselene enriquez ; 1911 walker avenue; monrovia, CA 91016
• MDR Report Key: 14439778
• Report Number: 2023826-2022-01596
• Device Sequence Number: 5733082
• Product Code: QCB
• UDI-Device Identifier: 00841542114707
• UDI-Public: 00841542114707
• 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,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/09/2022

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 Expiration Date: 10/31/2023
• Device Model Number: VTICM5_12.6
• 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: 04/29/2022
• Supplement Date Received by Manufacturer: 08/09/2022; 08/30/2022
• Initial Report FDA Received Date: 05/19/2022
• Supplement Report FDA Received Date: 08/09/2022; 08/30/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/31/2022
• 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
• Concomitant Medical Products and Therapy/Usage Dates: UNK.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 29 YR
• Patient Sex: Male