FDA Adverse Event
Malfunction
Summary report: N
DISPOSABLE VITRECTOMY LENS: WIDE VIEW
MDR report key: 9162142
·
Received October 7, 2019
Report
- Report Number
- 1222074-2019-00031
- Event Type
- Malfunction
- Date Received
- October 7, 2019
- Manufacturer
- D.O.R.C. DUTCH OPHTHALMIC RESEARCH CENTER (INTERNA
- Product Code
- HJK
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 0
D.O.R.C. WAS INFORMED BY THE CUSTOMER THAT COMPLAINT ARTICLES, TWO LENSES, ARE NOT AVAILABLE FOR INVESTIGATION. HOWEVER, IN CONNECTION WITH A SIMILAR COMPLAINT FROM THE SAME HOSPITAL FILED FEW DAYS LATER (DORC REFERENCE NUMBER (B)(4) WE RECEIVED TWO LENSES (WITH DIFFERENT LOT NUMBER). THESE LENSES ARE CURRENTLY UNDER INVESTIGATION. THE RESULTS WILL BE INCLUDED IN THE FINAL REPORT CONCERNING INCIDENT (B)(4).
Description of Event or Problem · 0
2 LENSES WERE DIRTY.
Additional Manufacturer Narrative · 1
AN INVESTIGATION WILL BE INITIATED AS SOON AS THE COMPLAINT ARTICLES ARE RECEIVED BY D.O.R.C.
Description of Event or Problem · 1
2 LENSES WERE DIRTY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 954608 | DISPOSABLE VITRECTOMY LENS: WIDE VIEW | VITRECTOMY CONTACT LENS, SINGLE-USE | HJK | D.O.R.C. DUTCH OPHTHALMIC RESEARCH CENTER (INTERNA | 2000402344 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |