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

Model Number	VTICM5_12.6
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Endophthalmitis (1835); Hypopyon (1913); Inflammation (1932); Intraocular Pressure Increased (1937); Pain (1994); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	10/19/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A4: unk, a5: unk, a6: unk, d6b: unk, h6: health impact- clinical code: 4581 - permanent loss of bcva, redness, light sensitivity.H6: health effect impact code: 4644 - ceftazidime, vancomycin.H6: health impact - additional surgery: 4625 - pars plana vitrectomy.H6 - work order search: no similar complaint was reported for units within the same lot.H6: 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.(b)(4).
Event or Problem Description
The reporter indicated the surgeon implanted a 12.6mm vticm5_12.6 implantable collamer lens, -11.00/+2.0/090 (sphere/cylinder/axis), into the patients left eye (os) on (b)(6) 2023.The patient was found to have endophthalmitis and permanent loss of bcva.Intraocular pressure (iop) check and anterior segment imaging were performed on (b)(6) 2023.Patient was prescribed medications for increased iop.Patient had hypopyon, fibrim net, cells in ac, with redness, severe light sensitivity and pain, initially diagnosed as tass due to fast course of signs and clear b-scan by doctor and retinal specialist.Patient had vitreous biopsy with intravitreal injection of vancomycin and ceftazidime to rule out and treat endophthalmitis as well as subtenon kenalog due to initial fast course of signs of tass.The next day, due to cells on vitreous b-scan, the patient had bilateral ppv (pars plana vitrectomy) with intravitreal injection of ceftazidime, vancomycin and vitreous culture.Vitreous culture grew pseudomona aeruginosa and currently the patient is hospitalized.The lens remained implanted.Additional information has been requested but none has been forthcoming.
Additional Manufacturer Narrative
B5: the patient is receiving iv meropenem, topical antibiotics and glaucoma meds.In the last examination by retinal specialist, she was still having pain in both eyes and periorbital inflammation that had been improved since initial hospitalization evaluated by ct and mri of the brain and orbits.Current ucva is nlp ou (b)(6) 2023).H6: health effect impact code: 4644 - meropenem.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 muniz ; 1911 walker avenue; monrovia, CA 91016 ; 6263037902
• MDR Report Key: 18136571
• Report Number: 2023826-2023-04906
• Device Sequence Number: 6559946
• Product Code: QCB
• UDI-Device Identifier: 00841542115124
• UDI-Public: 00841542115124
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: P030016
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/20/2023

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 04/30/2024
• Device Model Number: VTICM5_12.6
• 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: Not provided
• Supplement Date Received by Manufacturer: 11/20/2023
• Initial Report FDA Received Date: 11/14/2023
• Supplement Report FDA Received Date: 11/21/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/23/2022
• 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: Hospitalization; Required Intervention
• Patient Age: 29 YR
• Patient Sex: Female