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

Model Number	VTICM5_12.6
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	09/15/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Claim#: (b)(4).
Event or Problem Description
The reporter indicated that while the surgeon attempted to implant a 12.6mm vticmo12.6; -9.0/1.5/123 (sphere/cylinder/axis) implantable collamer lens into the patient's right eye (od) the lens tore during injection/delivery into the eye.There was patient contact with no patient injury.Intraoperatively the lens was removed and replaced with a back up lens of the same length/model.This occurred on (b)(6) 2022.The problem was resolved.The cause of the event was reported as user error with device causality; it was noted "when trying to fix placement began to bring it out to reinsert it and it tore; then placed back up lens".
Additional Manufacturer Narrative
Corrected data: b5- "the reporter indicated the surgeon implanted a 13.2mm vticm5_13.2 implantable collamer lens" should be corrected to "the reporter indicated that the surgeon implanted a 12.6mm vticm5_12.6 implantable collamer lens" claim# (b)(4).
Additional Manufacturer Narrative
Corrected data: b5- " the reporter indicated that the surgeon implanted a 13.2mm vticm5_13.2 implantable collamer lens of diopter -9.0/1.5/123 (sphere/cylinder/axis) into the patient's right eye (od) on (b)(6) 2022 when the lens tore/broke during injection/delivery into the eye.Reportedly "the icl was implanted upside down and during the process of removal the icl then tore." there was patient contact but no patient injury.The lens was implanted; removed and replaced intraoperatively with the same model/ length lens and the problem was resolved.The status of the eye was reported as "mild corneal edema but resolving plant to see him again tomorrow".The reporter indicated the cause of the event was user error and the device failed to perform as intended.Reportedly "when trying to fix placement began to bring it out to reinsert it and it tore then placed back up lens".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: 15491969
• Report Number: 2023826-2022-03317
• Device Sequence Number: 19280900
• Product Code: QCB
• UDI-Device Identifier: 00841542114837
• UDI-Public: 00841542114837
• Combination Product (Y/N): N
• Initial Reporter State: AL
• Initial Reporter Country: US
• PMA/510(K) Number: P030016
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2022
• 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,Followup
• Report Date (Section B): 09/15/2022

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: 07/31/2024
• Device Model Number: VTICM5_12.6
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• 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: 09/15/2022
• Supplement Date Received by Manufacturer: 12/21/2022; 12/26/2022
• Initial Report FDA Received Date: 09/27/2022
• Supplement Report FDA Received Date: 12/22/2022; 12/26/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/11/2022
• 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: INJECTOR MODEL-LIOLI-24, LOT#-UNK.
• Patient Age: 38 YR
• Patient Sex: Male