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.
[46872133]
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
[46872134]
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 april) 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
[50259889]
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 to the fda in supplemental reports.
Patient Sequence No: 1, Text Type: N, H10
[50259890]
A clinician ((b)(6)) who works at (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): (b)(6); procedure: plombe. (b)(6); procedure: cerclage, silicon oil, endolaser, peeling, decaline, 20 ga ppv. (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, antisbiotics 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
| Report Number | 3002807445-2016-00002 |
| MDR Report Key | 5706505 |
| Report Source | DISTRIBUTOR,FOREIGN,HEALTH PR |
| Date Received | 2016-06-08 |
| Date of Report | 2016-05-27 |
| Date of Event | 2016-04-18 |
| Date Mfgr Received | 2016-05-10 |
| Device Manufacturer Date | 2015-09-23 |
| Date Added to Maude | 2016-06-08 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR. PHIL CUSCUNA |
| Manufacturer Street | 2140 WINSTON PARK DR., UNIT 6 |
| Manufacturer City | OAKVILLE, ONTARIO L6H 5V5 |
| Manufacturer Country | CA |
| Manufacturer Postal | L6H 5V5 |
| Manufacturer Phone | 8290055 |
| Manufacturer G1 | LABTICIAN OPHTHALMICS, INC. |
| Manufacturer Street | 2140 WINSTON PARK DR., UNIT 6 |
| Manufacturer City | OAKVILLE, ONTARIO L6H 5V5 |
| Manufacturer Country | CA |
| Manufacturer Postal Code | L6H 5V5 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | LABTICIAN RETINAL IMPLANT |
| Generic Name | RETINAL IMPLANT |
| Product Code | HQJ |
| Date Received | 2016-06-08 |
| Model Number | S 1982-5 |
| Catalog Number | S 1982-5 |
| Lot Number | 42385 |
| Operator | PHYSICIAN |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | LABTICIAN OPHTHALMICS, INC |
| Manufacturer Address | 2140 WINSTON PARK DR., UNIT 6 OAKVILLE, ONTARIO L6H 5V5 CA L6H 5V5 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2016-06-08 |