MAUDE Adverse Event Report: ALCON RESEARCH, LLC - IRVINE TECHNOLOGY CENTER INFINITI VISION SYSTEM; UNIT, PHACOFRAGMENTATION

Model Number JAPAN

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

Patient Problems Unspecified Infection (1930); Inflammation (1932)

Event Date 04/08/2019

Event Type  Injury  

Manufacturer Narrative

Investigation including root cause analysis is in progress.A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when additional reportable information becomes available.The manufacturer internal reference number is: (b)(4).

Event Description

A customer reported that a patient experienced endophthalmitis following cataract surgery.The phaco handpiece was reused from the previous surgery.Only the phaco tip was exchanged to initiate surgery.

Event Description

Additional information was received.The patient underwent a vitrectomy procedure, in the right eye, one day following cataract surgery.

Manufacturer Narrative

The sample has been received and in-house evaluation is in progress.Investigation including root cause analysis is in progress.A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when additional reportable information becomes available.The manufacturer internal reference number is: (b)(4).

Manufacturer Narrative

Additional information provided in d.10., d.11., h.3., h.6., and h.10.There are multiple factors that could contribute to the occurrence of endophthalmitis.A patient¿s ocular flora or microorganisms that have colonized the surface structures (eyelids and conjunctiva) are the usual cause of infection, therefore isolating eyelids and eyelashes from the surgical field is crucial.The most common cultured microorganisms are gram-positive coagulase negative cocci (70%) with staphylococcus epidermis (s.Epidermis) the most prevalent.Deoxyribonucleic acid (dna) analyses of s.Epidermis strongly suggest that it is likely that commensal bacterial contaminating the anterior chamber at the time of surgery are responsible for most cases of endophthalmitis.According to the european society of cataract and refractive surgeons (escrs) and other reputable ophthalmic organizations, the most accepted practice to prevent is the topical use of povidone iodine 5% in the conjunctival sac before surgery.Antibiotics used days before surgery has been shown to decrease the bacterial load at the time of surgery.Povidone-iodine solution has broad antibiotic activity and has been shown to significantly decrease conjunctival and perilimbal flora.Meticulous prepping and draping of the patient before surgery are important as well, to isolate the eyelids and lashes from the surgical field.Finally, attempts should be made to decrease any postoperative patient risk factors, such as immunosuppression or systemic disorders that may affect the wound healing and the ability of the eye to ward off any inoculums of bacteria during cataract surgery.Intraoperative risk factors may be associated with an increased incidence of postoperative endophthalmitis.These include inadequate disinfection of the eyelid or conjunctiva, vitreous loss, or unplanned/unapparent ocular penetration.The system is a closed system.It is operated with a sterile single use consumable cassette which is designed to isolate the patient fluid path from the console itself.Any reusable surgical instrumentation (phaco handpiece) that would come into contact with the patient would be autoclaved by the user prior to surgery, per standard industry practices and the product directions for use (dfu).The phaco handpiece is a reusable device that must be reprocessed per the product dfu.There is no evidence that the design or performance of the system caused or contributed to this reported event of endophthalmitis.No further information was able to be obtained from this customer.However, the customer returned a phaco handpiece and ia handpiece for evaluation.The manufacturing device history record (dhr) was reviewed.Based on qa assessment, the product met specifications at the time of release.The phaco handpiece was received for evaluation.A visual assessment of the returned sample showed no visible non-conformities.The returned sample was connected to a calibrated system.The handpiece tuned successfully and completed a five-minute burn-in test with the system set at 100% ultrasonic and torsional power.The handpiece was connected to dynamic tuning fixture (dtf) for stroke length testing on the longitudinal and torsional movements, which found the handpiece to meet specifications.The handpiece was flushed for metal particulates testing.The sample was visually and microscopically analyzed and found to contain numerous fibers up to 920 ¿m in length and numerous dark reflective particles (up to 96 ¿m).One opened i/a threaded handpiece was returned for evaluation for the report of endophthalmitis.A review of the device history record traceable to the reported lot number indicates that the product was processed and released according to the product¿s acceptance criteria.A complaint history examination indicates there was one additional complaint associated with the lot for the reported issue from the same customer entity.The handpiece was manufactured in december 2008.A visual inspection of the i/a handpiece was performed and was deemed nonconforming.White residue, which appears to be a dried salts, is present on all the front adapter sides.Surgical residue material is present in the inside diameters of the male and female luers at the proximal end of the handpiece.The complaint sample cannot confirm the presence of endophthalmitis.The complaint does confirm that there is foreign material present in both the irrigation and aspiration luers, most likely surgical material.The cleaning process documented in the complaint file does not reflect the recommended cleaning instructions provided in the direction for use pamphlet.Based on the age of the handpiece the endophthalmitis issue does not point to a manufacturing issue.This handpiece is approximately 10 years old and has seen its useful life.All reusable handpieces are 100% visually inspected, functionally tested, and cleaned during the manufacturing process.Any surgical instrumentation that comes into contact with the patient should be cleaned and autoclaved by the user prior to surgery, per standard industry practices and company directions for use (dfu).The proper cleaning and sterilization of ophthalmic surgical instruments can help prevent the occurrence of endophthalmitis.A direction for use pamphlet with the recommended cleaning process is provided with the product.The directions for use also warns that a handpiece should be checked for damage prior to use and if observed should be immediately removed from service.Based on the information obtained, the root cause of the reported event cannot be determined conclusively.The manufacturer internal reference number is: (b)(4).

• Brand Name: INFINITI VISION SYSTEM
• Type of Device: UNIT, PHACOFRAGMENTATION
• Manufacturer (Section D): ALCON RESEARCH, LLC - IRVINE TECHNOLOGY CENTER; 15800 alton parkway; irvine CA 92618
• MDR Report Key: 8541254
• MDR Text Key: 142805766
• Report Number: 2028159-2019-00739
• Device Sequence Number: 1
• Product Code: HQC
• Combination Product (y/n): N
• PMA/PMN Number: K120912
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 08/29/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/23/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: JAPAN
• Device Catalogue Number: 8065751143
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/20/2019
• Date Manufacturer Received: 08/20/2019
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Patient Sequence Number: 1
• Treatment: ASSY,SHIP,OZIL INFI JAPAN; OZIL TORSIONAL PHACO HP; ULTRAFLOW I/A THREADED HANDPIECE; ULTRAFLOW IA THREADED HP; OZIL TORSIONAL PHACO HP; ULTRAFLOW IA THREADED HP
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 81 YR