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

Model Number	VTICMO 13.2
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	02/14/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The reporter indicated that a 13.2mm, vticmo13.2 -16.50/1.0/033 (sphere/cylinder/axis) implantable collamer lens was implanted and removed due to it being implanted upside down.No patient injury.Attempts to obtain additional information have not been successful.If additional information is received a supplemental medwatch report will be submitted.
Additional Manufacturer Narrative
Type of investigation - lens work order search: no similar complaint type events reported for units within the same lot.Claim#: (b)(4).
Additional Manufacturer Narrative
Corrected data: d4.Model#: "vicmo 13.2" should be removed and "vticmo13.2" should be added.H6-health effect- impact code: "2645" should be removed and code "2199" should be added.H6- medical device problem code: "3026" should be added.Additonal information: b5- the reporter indicated that the surgeon implanted a 13.2mm vticmo 13.2 implantable collamer lens of diopter -16.50/1.0/033 (sphere/cylinder/axis) into the left eye (os) on (b)(6)2023.The lens was implanted upside down.There was patient contact but no patient injury.The lens was implanted, removed and replaced intraoperatively with a lens of the same parameters and the problem was resolved.Additional information provided: "original lens removed and replaced with back up lens.Original lens went in upside down.No complication, patient doing well".The reporter indicated the cause of the event was the device.Cause details provided: " lens flipped during delivery into eye.Lens was upside down.Lens cut in ½".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 enriquez ; 1911 walker avenue; monrovia, CA 91016
• MDR Report Key: 16615097
• Report Number: 2023826-2023-01085
• Device Sequence Number: 6149075
• Product Code: QCB
• UDI-Device Identifier: 00841542121132
• UDI-Public: 00841542121132
• Combination Product (Y/N): N
• Initial Reporter State: IN
• 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: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/24/2023

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: 04/30/2024
• Device Model Number: VTICMO 13.2
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/10/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/24/2023
• Supplement Date Received by Manufacturer: 03/24/2023
• Initial Report FDA Received Date: 03/24/2023
• Supplement Report FDA Received Date: 12/22/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/19/2022
• 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: Required Intervention
• Patient Sex: Male