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

Model Number	VTICM513.2
Medical Device Problem Codes	Off-Label Use (1494); 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)
Date of Event	04/07/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The reporter indicated that the surgeon implanted a 13.2mm vticm513.2 implantable collamer lens of a -9.0/4.0/41 (sphere/cylinder/axis) as a replacement into the patient's eye.Reportedly, "an off-label pseudophakic patient who had many prior eye surgeries.He tried the 13.7 icl implant, didn't sit well due to patient anatomy, removed the lens, and tried to implant the 13.2 and also didn't sit right so he removed the icl.".
Additional Manufacturer Narrative
A4-a6:unk.H6: off-label - pre-existing psudophakic patient with many prior surgeries.Claim# (b)(4).
Additional Manufacturer Narrative
Corrected data: h6-medical device problem code: "3189" should be removed and code "2993" should be added.H6- type of investigation code: 4110- lens work order search-no similar complaint event(s) within associated lots were found.G2- "foreign" and "distributor/importer" should be removed.Claim# (b)(4).
Additional Manufacturer Narrative
Additional data: h6-health effect- impact code: "4627" should be removed and code "2199" should be added.H6- medical device code: "2993" should be removed and "3189" should be added.B5- the reporter indicated that the surgeon a 13.2mm vticm5_ 13.2 implantable collamer lens of diopter -9.00/+4.00/041 (sphere/cylinder/axis) into the patient's eye right (od) as a replacement lens on (b)(6) 2023.The patient experienced an excessive vault.Reportedly "wrong size, unstable in sulcus on top of iol." the lens was implanted and removed intraoperatively.The problem was resolved.Status of the eye: "quiet".The cause of the event was a patient related factor and its unknown if the device failed to perform as intended.Cause details provided: "became apparent intraoperatively that there was compromise to the zonule and the capsular bag was unstable.It was not possible to fit the icl in its proper orientation due to sizing as well as instability of the capsule".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: 16897860
• Report Number: 2023826-2023-01715
• Device Sequence Number: 17677637
• Product Code: QCB
• UDI-Device Identifier: 00841542116497
• UDI-Public: 00841542116497
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• 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: Foreign,Health Professional,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/12/2023

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: 10/31/2024
• 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: 04/12/2023
• Supplement Date Received by Manufacturer: 06/27/2023; 08/30/2023
• Initial Report FDA Received Date: 05/09/2023
• Supplement Report FDA Received Date: 06/27/2023; 09/05/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/07/2022
• 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.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown