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

Model Number	VTICMO13.2
Medical Device Problem Code	Unintended Movement (3026)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H6 - work order search: no similar complaint was reported for units within the same lot.Claim # (b)(4).
Event or Problem Description
The reporter indicated the surgeon implanted a 13.2mm vticmo13.2 implantable collamer lens, -15.50/+1.5/174 (sphere/cylinder/axis).The lens flipped inside the eye, the surgeon attempted to reposition the lens but was unsuccessful.The lens was removed and the backup lens was implanted.Additional information has been requested but none has been forthcoming.
Additional Manufacturer Narrative
Corrected data: b5: the surgeon implanted a 13.2mm vticmo13.2 implantable collamer lens -15.50/+1.5/174 (sphere/cylinderl/axis) into the patients left eye (os).This was the replacement lens for mfr report # 2023-2023-03835 and the lens remained implanted.Claim # (b)(4).
Additional Manufacturer Narrative
Corrected data: b5- originally the claim was determined to be reportable, but upon further review was determined to not meet definition of a complaint.However, the claim cannot be voided as an mdr has already been submitted.Replacement/back up lens for mfr report # 2023-2023-03835.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 SURGICAL COMPANY; 1911 walker avenue; monrovia CA 91016
• Manufacturer Contact: joselene muniz ; 1911 walker avenue; monrovia, CA 91016 ; 6263037902
• MDR Report Key: 17672700
• Report Number: 2023826-2023-03836
• Device Sequence Number: 6116296
• Product Code: QCB
• UDI-Device Identifier: 00840311327096
• UDI-Public: 00840311327096
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: P030016
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/03/2023

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: 02/28/2026
• Device Model Number: VTICMO13.2
• 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: 08/03/2023
• Supplement Date Received by Manufacturer: 10/13/2023; 11/13/2023
• Initial Report FDA Received Date: 09/01/2023
• Supplement Report FDA Received Date: 10/13/2023; 11/13/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/07/2023
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown