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

Model Number	VITCM513.2
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
Additional Manufacturer Narrative
H6: work order search found no similar complaints within associated lots.Claim# (b)(6).
Event or Problem Description
The reporter indicated that a 13.2mm vticm513.2 implantable collamer lens of -9.50/3.0/140 tore during delivery into the eye.Reportedly, "was injecting the icl in the eye, the icl got stuck in the injector as he was pulling out the plunger.He then pulled out the injector, plunger and icl," and "there was a brief patient contact.Icl was pulled out with no issue.".
Additional Manufacturer Narrative
Additional information: b5: the reporter indicated that a 13.2mm vticm513.2 implantable collamer lens of -9.50/3.0/140 tore during delivery into the eye.On (b)(6) 2023 the lens was removed intraoperatively.On (b)(6) 2023 the lens was replaced with a similar lens model.This resolved the problem.Reportedly, "was injecting the icl in the eye, the icl got stuck in the injector as he was pulling out the plunger.He then pulled out the injector, plunger and icl," and "there was a brief patient contact.Icl was pulled out with no issue." cause of the event was user error.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: 17222199
• Report Number: 2023826-2023-02602
• Device Sequence Number: 7097457
• Product Code: QCB
• UDI-Device Identifier: 00841542116541
• UDI-Public: 00841542116541
• Combination Product (Y/N): N
• 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): 06/05/2023

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: 07/31/2024
• Device Model Number: VITCM513.2
• 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: 06/05/2023
• Supplement Date Received by Manufacturer: 07/31/2023
• Initial Report FDA Received Date: 06/28/2023
• Supplement Report FDA Received Date: 08/30/2023
• Date Device Manufactured: 03/22/2023
• 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
• Patient Sex: Unknown