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

Model Number	VTICM513.2
Medical Device Problem Code	No Apparent Adverse Event (3189)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
The reporter indicated that a 13.2mm vticm513.2 implantable collamer lens of -8.00/4.0/088 became damaged during loading.A replacement lens was implanted.Reportedly, "no patient contact.".
Additional Manufacturer Narrative
H6: work order search found no similar complaints within associated lots.Claim# (b)(4).
Additional Manufacturer Narrative
Additional data: b5- the reporter indicated the surgeon noted a 13.2mm vticm5_13.2 implantable collamer lens of diopter -8.00/4.0/088 (sphere/cylinder/axis) reportedly was "damaged during loading.No, patient contact"and "it just got dropped or something".A back up lens of the same parameters was implanted and the problem was resolved.The reporter indicated the cause of the event was user error.Reportedly "user error in loading".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.Reportedly was "damaged during loading.No, patient contact" and "it just got dropped or something".The reporter indicated the cause of the event was user error.Reportedly "user error in loading".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 ; 8002927902
• MDR Report Key: 17561599
• Report Number: 2023826-2023-03507
• Device Sequence Number: 6665553
• Product Code: QCB
• UDI-Device Identifier: 00841542116350
• UDI-Public: 00841542116350
• Combination Product (Y/N): N
• Initial Reporter State: NE
• Initial Reporter Country: US
• 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: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/28/2023

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: 11/30/2024
• 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: 05/25/2023
• Supplement Date Received by Manufacturer: 11/28/2023; 12/07/2023
• Initial Report FDA Received Date: 08/16/2023
• Supplement Report FDA Received Date: 12/06/2023; 12/07/2023
• Date Device Manufactured: 05/01/2023
• 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: UNK.
• Patient Sex: Unknown