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

Model Number VTICM5_12.6

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Endophthalmitis (1835); Hypopyon (1913); Inflammation (1932); Intraocular Pressure Increased (1937); Pain (1994); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 10/19/2023

Event Type  Injury  

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 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.

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)
• Type of Device: 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
• MDR Text Key: 328109252
• Report Number: 2023826-2023-04906
• Device Sequence Number: 1
• Product Code: QCB
• UDI-Device Identifier: 00841542115124
• UDI-Public: 00841542115124
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P030016
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 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
• Device Operator: 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
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 11/14/2023
• Supplement Dates Manufacturer Received: 11/20/2023
• Supplement Dates FDA Received: 11/21/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 05/23/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 29 YR
• Patient Sex: Female