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

Model Number	VTICM5_12.6
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); No Apparent Adverse Event (3189)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Serious Injury
Event or Problem Description
The reporter indicated the surgeon was loading a 12.6mm vticm5_12.6 implantable collamer lens, -06.50/+1.0/079 (sphere/cylinder/axis), and the lens tore.Unknown if there was any patient contact.The cause of the event was unknown.
Additional Manufacturer Narrative
H6 - work order search: no similar complaint was reported for units within the same lot.(b)(4).
Additional Manufacturer Narrative
Corrected data: b5- the reporter indicated that the surgeon noted a 12.6mm vticm5_12.6 implantable collamer lens of diopter -6.50/1.0/079 (sphere/cylinder/axis) tore during loading.It is unknown if there was patient contact.A back up lens was attempted to be implanted into the left eye (os) but that also tore.Reportedly "on the second eye from the same lot i used 2 and all torn".The problem was not resolved.Cause of event is unknown: "i am not sure.I never had this happen before and i have used the lioli injector in the past.I am working with (b)(6) to try and figure this out.Trying to see if i need to change technique." h6-health effect- impact code: "4614" should be added.H6- medical device code: "3189" should be removed and "2993" should be added.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: 17083874
• Report Number: 2023826-2023-02183
• Device Sequence Number: 17659862
• Product Code: QCB
• UDI-Device Identifier: 00841542114479
• UDI-Public: 00841542114479
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• 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
• Report Date (Section B): 05/18/2023

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: 08/31/2024
• 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: 05/18/2023
• Supplement Date Received by Manufacturer: 10/30/2023
• Initial Report FDA Received Date: 06/07/2023
• Supplement Report FDA Received Date: 10/30/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/08/2022
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown