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U.S. Department of Health and Human Services

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

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ALCON RESEARCH, LTD. - ALCON PRECISION DEVICE MONARCH III IOL DELIVERY SYSTEM, INJECTOR LENS, GUIDE, INTRAOCULAR Back to Search Results
Model Number III
Device Problem Patient-Device Incompatibility (2682)
Patient Problems Corneal Edema (1791); Hypopyon (1913); Inflammation (1932); Retinal Detachment (2047)
Event Date 10/01/2017
Event Type  Injury  
Manufacturer Narrative
Additional information provided. Product evaluation: 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. 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).
 
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. (b)(4).
 
Event Description
An ophthalmic surgeon reported that three days following a cataract removal with intraocular lens (iol) implant procedure, the patient presented with endophthalmitis. Corneal edema, retinal detachment, vitritis, hypopyon and fibrinous deposits on the implant were noted. The patient was hospitalized for six days and was treated with intravenous and intravitreal antibiotics (three intravitreal treatments in total). Vitrectomy was performed on (b)(6) 2017. It was indicated that the outcome of the event was loss of the eye. Clarification was received, indicating that the reporting facility cannot determine which medical device may have contributed to the event. The surgery was uneventful, there were no new members of the sterilization team, and there had been no recent changes in procedures. The patient's other eye had been operated on 15 days before, and the postoperative recovery had been completely normal. It was also clarified that the patient 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.
 
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Brand NameMONARCH III IOL DELIVERY SYSTEM, INJECTOR
Type of DeviceLENS, 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 Key7251572
MDR Text Key278192891
Report Number2523835-2018-00059
Device Sequence Number1
Product Code KYB
Combination Product (y/n)N
Reporter Country CodeFR
PMA/PMN Number
K063155
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional
Reporter Occupation
Type of Report Initial,Followup
Report Date 05/24/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/08/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberIII
Device Catalogue Number8065977773
Device Lot NumberASKU
Other Device ID Number380659777738
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/27/2018
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/26/2018
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 Treatment Data
Date Received: 02/08/2018 Patient Sequence Number: 1
Treatment
BETADINE PREP; BSS; DEXAMETHASONE EYE DROPS; INTRACAMERAL LIDOCAINE; MONARCH III CARTRIDGE; PHYSIOVISC; SN60WF 25.5D IOL; STELARIS SYSTEM; UNSPECIFIED I/A HANDPIECE; UNSPECIFIED PHACO HANDPIECE; VENTURI PUMP
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