LABTICIAN RETINAL IMPLANT S 1982-5

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor,foreign,health pr report with the FDA on 2016-06-08 for LABTICIAN RETINAL IMPLANT S 1982-5 manufactured by Labtician Ophthalmics, Inc.

Event Text Entries

[46789927] Labtician believes that the likelihood of infection arising from its round sponge is very low. Although it is impossible to rule out (at this time) labtician comes to this preliminary belief: similar related infections during the same month not involving labtician medical devices indication that infection also involved area inside the eye whereas the labtician implant remains outside the eye review of device history record revealed no nonconformances or unusual anomalies lack of similar complaints for this device lot number lack of similar complaint in history of retinal implant sales (30 years) no changes to the manufacturing process including sterilization process; consistently low bioburden results (1. 3 cfu - recent bioburden result for the particular device) we continue to engage in dialogue with our distributor who is in contact with the physician and are carefully monitoring customer communications. In addition, we have sent representative samples of this device (with same lot number as the device involved in the adverse event) to a third party for product sterility testing. The results, along with any additional information obtained, will be forwarded t the fda in supplemental reports.
Patient Sequence No: 1, Text Type: N, H10


[46789928] A clinician (prof. (b)(6)) who works at university (b)(6), informed labtician's distributor (b)(4), that three patients incurred infections following ophthalmic procedures that took place between the dates (b)(6) 2016 (exact dates for each of the patients involved were not provided). The patients involved (and their particular surgical procedure were as follows (as reported by the clinician): patient 1: male, (b)(6); procedure: plombe. Patient 2: female, (b)(6); procedure: cerclage, silicon oil, endolaser, peeling, decaline, 20 ga ppv. Patient 3: female, (b)(6) procedure: ppv, cerclage and gas. In addition to the 3 reported cases to labtician, the clinician reported to labtician that there have been other infections in the same month (of (b)(6)) that did not involve any labtician product - and logically we were not contacted for those. As a precautionary measure the clinician informed all manufacturers of medical devices who were involved in the various procedures - and this included labtician. In all three cases labtician's round sponge - s1982-5 (lot # 42385) was utilized during the procedure. Additional information has been requested by labtician, however based on preliminary requests for data, the clinician reported the treatment of the patients as (quoted): "plombe and cerglace distance, systems and local antibiose, vitrectomy transmigration endophthalmitis, antibiotics flushing. " there is evidence to suggest here that the infection either occurred solely from within the eye (endophthalmitis) or possibly both inside and outside of the eye. "endophthalmitis" is an infection inside the eyeball (globe). The inside of the eye is sealed and sterile and typically not exposed to external organisms, such as bacteria or fungus. Because the tissues within the eyeball are very delicate, endophthalmitis is very serious and can lead to blindness and even loss of the eye itself. One important note regarding the labtician round sponge is that it is used outside the actual eye.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number3002807445-2015-00001
MDR Report Key5706019
Report SourceDISTRIBUTOR,FOREIGN,HEALTH PR
Date Received2016-06-08
Date of Report2016-05-27
Date of Event2016-04-18
Date Mfgr Received2016-05-10
Device Manufacturer Date2015-09-23
Date Added to Maude2016-06-08
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag0
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactMR. PHIL CUSCUNA
Manufacturer Street2140 WINSTON PARK DR., UNIT 6
Manufacturer CityOAKVILLE, ONTARIO L6H 5V5
Manufacturer CountryCA
Manufacturer PostalL6H 5V5
Manufacturer Phone8290055
Manufacturer G1LABTICIAN OPHTHALMICS, INC.
Manufacturer Street2140 WINSTON PARK DR., UNIT 6
Manufacturer CityOAKVILLE, ONTARIO L6H 5V5
Manufacturer CountryCA
Manufacturer Postal CodeL6H 5V5
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameLABTICIAN RETINAL IMPLANT
Generic NameRETINAL IMPLANT
Product CodeHQJ
Date Received2016-06-08
Model NumberS 1982-5
Catalog NumberS 1982-5
Lot Number42385
OperatorPHYSICIAN
Device AvailabilityN
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerLABTICIAN OPHTHALMICS, INC
Manufacturer Address2140 WINSTON PARK DR., UNIT 6 OAKVILLE, ONTARIO L6H 5V5 CA L6H 5V5


Patients

Patient NumberTreatmentOutcomeDate
101. Required No Informationntervention 2016-06-08

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