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

Model Number	VTICM5_13.2
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Toxic Anterior Segment Syndrome (TASS) (4469)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
H6- investigation type code: 4110- lens work order search- one similar complaint event(s) within associated lots were found.H11- manufacturer narrative: a review of the device labeling was completed.Ocular inflammation is identified in the labeling as a known potential adverse event following icl implantation.The evo/evo+ icl directions for use (dfu) states under adverse events: as with implantation of other types of intraocular lenses, potential adverse events can include, but are not limited to infection and iritis.Toxic anterior segment syndrome (tass) is an acute sterile postoperative inflammation that can occur after uncomplicated or complicated intraocular surgery.Improper sterilization and contamination of surgical instruments remains the most common risk factor associated with tass.This was confirmed by the reported information of both surgeons thinking the internal sterilization process and likely the reusable manipulator contributed.Status of both patients improved with lens remaining implanted.Claim# (b)(4).
Event or Problem Description
Report from a facility on (b)(6) 2024 indicated following an implantable collamer lens (icl) implantation procedure, tass was diagnosed in the patient's right eye (od).The lioli injector delivery system was used.The reporter stated that the surgeon thought most likely cause was the sterilization process likely with the manipulator.There is internal investigation of facility sterilization methods since a new person was performing the process.The latest information obtained on (b)(6) 2024 indicated the patient is doing better and no explant was needed.If additional information is received a supplemental medwatch report will be submitted.
Additional Manufacturer Narrative
Additional information: h6- type of investigation code: 3331- device history record (dhr) review: based on the results of the investigation, all released devices from the associated work order(s), including the suspected device, have been manufactured within established process parameters; and there is no indication that the manufacturing and processing of the device contributed to the complaint issue.Corrected data: b5- report from a facility on (b)(6) 2024 indicated that the following an implantable collamer lens (icl) implantation procedure, tass was diagnosed in the patient's right eye (od).The lioli injector delivery system was used.Additional information stated patient va was 20/15 and was happy and well.The reporter stated that the surgeon thought most likely cause was the sterilization process likely with the manipulator.The latest information obtained on (b)(6) 2024 indicated the patient is doing better and no explant is needed.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: 19924839
• Report Number: 2023826-2024-03189
• Device Sequence Number: 8083570
• Product Code: QCB
• UDI-Device Identifier: 00840311311378
• UDI-Public: 00840311311378
• 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
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/12/2024

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?: No
• Operator of Device: Health Professional
• Device Model Number: VTICM5_13.2
• 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: 07/12/2024
• Supplement Date Received by Manufacturer: 09/03/2024
• Initial Report FDA Received Date: 08/06/2024
• Supplement Report FDA Received Date: 09/04/2024
• Date Device Manufactured: 11/07/2023
• 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
• Concomitant Medical Products and Therapy/Usage Dates: CARTRIDGE MODEL: SFC-45: LOT# UNK.; FOAM TIP PLUNGER (FTP), LOT# UNK.; MSI-PF, LOT# UNK.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown