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

Model Number	VTICM512.6
Medical Device Problem Codes	Inadequacy of Device Shape and/or Size (1583); Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H6: user error.(b)(4).
Event or Problem Description
The reporter indicated that a 12.6mm vticm512.6 implantable collamer lens of -12.0/1.0/074 (sphere/cylinder/axis) was implanted as a replacement into the patient's right eye (od) (b)(6) 2023, due to excessive vault and significant reduction of iridocorneal angles.Cause of the event was user error.The reporter said, "i put in a 13.2mm and should have been 12.6 in the sight." the problem was resolved.Reportedly, "the calculation called for 13.2mm but it was way too big.12.6mm still had a 500+m vault.".
Additional Manufacturer Narrative
Additonal data: b5- the reporter indicated that the surgeon implanted a 12.6mm vticm5_12.6 implantable collamer lens of diopter -12.00/+1.00/074 (sphere/cylinder/axis) into the patient's right eye (od) on (b)(6) 2023 as a replacement lens.The patient experienced an excessive vault- "12.6mm still had a 500+m vault".Reportedly "this has been resolved.Per dr.Sharpe: the 13.2 mm lens was way too big.The 12.6 mm lens was slightly big but just fine.It's all good now.The patient is seeing well postoperatively." the lens remains implanted and the problem was resolved.The reporter indicated the cause of the event was user error.Reportedly " i think it was totally my fault in the mismeasure of her white to white.Not a device problem".H6- investigation type code: 4110- lens work order search-no similar complaint event(s) within associated lots were found.G2- "foreign" and "distrubutor/importer" should be removed.Claim# (b)(4).

• Brand Name: IMPLANTABLE COLLAMER LENS (ICL)
• Common Device Name: PHAKIC TORIC INTRAOCULAR LENS
• Manufacturer (Section D): STAAR SURGICAL COMPANY; 1911 walker avenue; monrovia CA 91016
• Manufacturer (Section G): STAAR SUGICAL COMPANY; 1911 walker avenue; monrovia CA 91016
• Manufacturer Contact: joselene muniz ; 1911 walker avenue; monrovia, CA 91016 ; 6263037902
• MDR Report Key: 16970382
• Report Number: 2023826-2023-01849
• Device Sequence Number: 17506023
• Product Code: QCB
• UDI-Device Identifier: 00841542115247
• UDI-Public: 00841542115247
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: P030016
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/24/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 07/31/2024
• Device Model Number: VTICM512.6
• 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: 04/24/2023
• Supplement Date Received by Manufacturer: 06/30/2023
• Initial Report FDA Received Date: 05/19/2023
• Supplement Report FDA Received Date: 06/30/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/22/2022
• 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.
• Patient Sex: Unknown