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

Model Number	VTICM513.2
Medical Device Problem Codes	Unintended Movement (3026); No Apparent Adverse Event (3189)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/28/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H6: work order search: no similar complaints within associated lots were found.Claim# (b)(4).
Event or Problem Description
The reporter indicated that a 13.2mm vticm513.2 implantable collamer lens of -11.0/1.0/106 (sphere/cylinder/axis) was implanted upside down into the patient's right eye (od).On (b)(6) 2023, the lens was intraoperatively removed and replaced for a same size lens.Cause of the event is unknown.Reportedly, "flipped and needed to replaced.Haptic damaged during removal." the problem was resolved.Status of the eye is, "successful sugery, lens flipped replaced.".
Additional Manufacturer Narrative
Corrected data: h6: health effect - impact code: "4629" should be removed and "2199" should be added.H6- medical device problem code: "3189" should be added.B5: the reporter indicated that a 13.2mm vticm5_13.2 implantable collamer lens of diopter -11.0/1.0/106 (sphere/cylinder/axis) was implanted upside down into the patients right eye (od) on (b)(6) 2023.Reportedly "flipped lens during insertion, replaced.Haptics damaged during removal".The len was implanted, removed and replaced intraoperatively with the same model, length lens and the problem was resolved.Status of the eye: "successful surgery, lens flipped and replaced".The cause of the event is unknown and the device failed to perform as intended.Cause details: "flipped lens during insertion, replaced.Haptic damaged during removal." 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: 17027928
• Report Number: 2023826-2023-02114
• Device Sequence Number: 7040104
• Product Code: QCB
• UDI-Device Identifier: 00840311311200
• UDI-Public: 00840311311200
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: P030016
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/05/2023

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: 01/31/2026
• Device Model Number: VTICM513.2
• 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: 05/05/2023
• Supplement Date Received by Manufacturer: 07/06/2023
• Initial Report FDA Received Date: 05/30/2023
• Supplement Report FDA Received Date: 07/07/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/13/2023
• 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: CARTRIDGE MODEL: SFC-45 - LOT# UNK; FOAM TIP PLUNGER - LOT# 1550839; INJECTOR MODEL: MSI-PF - LOT# 1640534
• Patient Age: 25 YR
• Patient Sex: Female