MAUDE Adverse Event Report: ALCON RESEARCH, LTD. - ALCON PRECISION DEVICE MONARCH III IOL DELIVERY SYSTEM, INJECTOR; LENS, GUIDE, INTRAOCULAR

Model Number III

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

Patient Problems Endophthalmitis (1835); Unspecified Infection (1930)

Event Date 09/18/2017

Event Type  Injury  

Manufacturer Narrative

Samples were received by a company representative and are in transit to the manufacturing site for investigation.Investigation including root cause analysis will be completed.A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when additional reportable information becomes available.A review of the device history records traceable to two possible lot numbers indicates that the product was processed and released according to the product¿s acceptance criteria.A complaint history examination indicates there were no additional complaints associated with the lots for the reported issue.The manufacturer internal reference number is: (b)(4).

Event Description

A surgeon reported via a health authority that a patient experienced an enterococcus faecalis infection four days following a cataract procedure with intraocular lens (iol) implant on her right eye (od).Endophthalmitis was observed with chemosis, retinal detachment, hypopyon, and corneal edema.The patient was hospitalized for nine days and treated with intravitreal and intravenous antibiotics.A vitrectomy was performed on (b)(6) 2017.It was noted that antibiotic eye drops had been prescribed since the first postoperative day.It was reported that the symptoms were continuing and that functional loss of the eye occurred.Clarification was received, indicating that the reporting facility cannot determine which medical device may have contributed to the event.It was noted that no samples can be provided.The surgery was uneventful, there were no new members of the sterilization team, and there had been no recent changes in procedures.Confirmation was received that the lens was not explanted.Additional information was received, indicating that the injector handpieces are suspected to have contributed to the reported event; samples are available.This is one of four medical device reports for this issue from this facility.

Manufacturer Narrative

Additional information provided.Nine (9) handpiece injectors were returned for evaluation.There are five (5) samples from one lot and four (4) samples from a second lot.It is not known which sample or lot is involved with the complaint issues.The handpiece injectors were manufactured in november and december of 2014.Samples 1 ¿ 5 (first possible lot) visual inspections of the iol handpiece injectors were performed and three were deemed conforming and two samples (#4 and #5) were deemed nonconforming.The two nonconforming injectors have a very light brown oily film present on the rounded back section of the plunger.A functional thread to barrel engagement check was performed and deemed conforming for all samples.A dimensional plunger position height check was performed and deemed conforming for the three samples with conforming visual attributes.An accurate test could not be performed on the two nonconforming visual injectors as the plunger would not ascend properly (very slow) due to the oily film.Injector samples #4 and #5 from the first possible lot were sent to the particulate lab for analysis of the film present on the plunger.The lab analysis results indicated the foreign material to be polysorbate 80.Polysorbate 80 is a water-soluble yellow liquid that is a surfactant that appears to have been used by the end user to reduce the friction when advancing the injector plunger during its use.Samples 6 ¿ 9 (second possible lot) visual inspections of the iol handpiece injectors were performed and all four samples were deemed conforming.A functional thread to barrel engagement check was performed and deemed conforming for all samples.A dimensional plunger position height check was performed and deemed conforming for all four samples.The evaluation cannot confirm the approximately three-year-old injectors returned were the cause of the inflection.It is not known if the polysorbate 80 contributed to the infection.The source of this liquid did not originate from any part of any manufacturing process for this product.The root cause for the infection cannot be determined from this evaluation, but does not point to a manufacturing issue.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 an infection.A direction for use pamphlet with the recommended cleaning process is provided with the product.The manufacturer internal reference number is: (b)(4).

• Brand Name: MONARCH III IOL DELIVERY SYSTEM, INJECTOR
• Type of Device: LENS, GUIDE, INTRAOCULAR
• Manufacturer (Section D): ALCON RESEARCH, LTD. - ALCON PRECISION DEVICE; 714 columbia avenue; sinking spring PA 19608
• Manufacturer (Section G): ALCON RESEARCH, LTD. - ALCON PRECISION DEVICE; 714 columbia avenue; sinking spring PA 19608
• Manufacturer Contact: nadia bailey ; 6201 south freeway; mail stop ab2-6; fort worth, TX 76134 ; 8176152230
• MDR Report Key: 7249309
• MDR Text Key: 99301015
• Report Number: 2523835-2018-00056
• Device Sequence Number: 1
• Product Code: KYB
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K063155
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 05/31/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/07/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: III
• Device Catalogue Number: 8065977773
• Device Lot Number: ASKU
• Other Device ID Number: 380659777738
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/27/2018
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/01/2018
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 82 YR