MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2019-01-29 for TP71M-0175+017530 TP manufactured by Synergeyes, Inc..
[134346612]
Follow-up with dr. (b)(6) on (b)(6) 2019: patient issue has resolved as of (b)(6) 2019.
Patient Sequence No: 1, Text Type: N, H10
[134346613]
On october 4, 2018: dr. (b)(6)'s office called consultation to report that pt. Had corneal abrasions two times (x2). Treated with steroid/antibiotic treatment combo tobradex. Doctor thought first abrasion was due to foreign body (fb). Then second abrasion occured due to central bearing. Original order sent in as regular cornea. Viewing topography sent today (4 october 2018) early pmd (pellucid marginal degeneration). Need to be re-fit. Will speak to pt. Regarding cost/cgh. Patient injury form sent to doctor. On december 10, 2018: patient injury form and two labeled lenses received at customer care/returns dept. Patient injury form stated the following: potential patient injury codes: eye care professional checked off 105- other injury. Patient injury information: checked off yes; the injury occured during the 90 day fitting period. Right eye (od) was uncomfortable, removed lenses mid-day, "feel" decreased comfort, right eye (od). Could not remove lens (b)(6), slept in them overnight. Eyelash appeared to be trapped under the lens. Checked off yes; the patient has pre-existing condition(s) (dry eyes) that may have caused or contributed to the event. Checked off yes; medical treatment was required to resolve the injury. Patient "treatmewnt" information: treatment was (the) therapeutic, tobradex od (right eye) qid (4 times a day) for x2 weeks. D/c (discontinue) contact lens wear. Condition has not resolved as of (b)(6) 2018. Patient to return on (b)(6) 2018 to check va (vision awareness) "ans" assess cornea. Decreased va (vision awareness) od (right eye) will reassess @ next follow-up. On (b)(6) 2018: abrasion improved. On (b)(6) 2018: to (topography) spk (superficial punctate keratitis) od (right eye)- cleared up 2 weeks later. On (b)(6) 2019: follow-up from consultation with doctor's office. Eye care professional confirmed the injury was treated therapeutically and not prophylactically with tobradex qid (four times a day) x 10 days to reduce swelling of secondary edema, no active infection.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3005087645-2019-00002 |
| MDR Report Key | 8285111 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2019-01-29 |
| Date of Report | 2019-01-04 |
| Date of Event | 2018-08-18 |
| Date Mfgr Received | 2018-12-10 |
| Device Manufacturer Date | 2018-07-24 |
| Date Added to Maude | 2019-01-29 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MS. NORA YORK |
| Manufacturer Street | 2232 RUTHERFORD. ROAD |
| Manufacturer City | CARLSBAD 920088836 |
| Manufacturer Country | US |
| Manufacturer Postal | 920088836 |
| Manufacturer Phone | 7604449636 |
| Manufacturer G1 | SYNERGEYES, INC |
| Manufacturer Street | 2232 RUTHERFORD ROAD |
| Manufacturer City | CARLSBAD CA 920088836 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 920088836 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Generic Name | DUETTE PROGRESSIVE CN WITH TANGIBLE HYDRA-PEG |
| Product Code | HQD |
| Date Received | 2019-01-29 |
| Returned To Mfg | 2018-12-10 |
| Model Number | TP71M-0175+017530 |
| Catalog Number | TP |
| Lot Number | 082191 |
| Operator | LAY USER/PATIENT |
| Device Availability | R |
| Device Age | 6 MO |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SYNERGEYES, INC. |
| Manufacturer Address | 2232 RUTHERFORD CARLSBAD CA 920088836 US 920088836 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2019-01-29 |