FDA Adverse Event
Malfunction
Summary report: N
IMPLANTABLE COLLAMER LENS (ICL)
MDR report key: 17401157
·
Received July 26, 2023
Report
- Report Number
- 2023826-2023-03122
- Event Type
- Malfunction
- Date Received
- July 26, 2023
- Date of Event
- June 28, 2023
- Report Date
- July 6, 2023
- Manufacturer
- STAAR SURGICAL COMPANY
- Product Code
- MTA
- UDI-DI
- 00841542119399
- PMA / PMN Number
- P030016
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AZ, US
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
Additional Manufacturer Narrative · 0
D10: LIOLI LOT# FCK1702. CLAIM# (B)(4).
Additional Manufacturer Narrative · 0
B5 - LENS WAS INTRAOPERATIVELY IMPLANTED, REMOVED AND REPLACED. CLAIM# (B)(4).
Additional Manufacturer Narrative · 0
B5: LENS WAS REMOVED AND REPLACED. CLAIM# (B)(4).
Additional Manufacturer Narrative · 0
H6: WORK ORDER SEARCH: ONE SIMILAR COMPLAINT WAS FOUND WITHIN ASSOCIATED LOTS. CLAIM# (B)(4). CLAIM# (B)(4).
Description of Event or Problem · 0
THE REPORTER INDICATED THAT 13.2MM VICM513.2 IMPLANTABLE COLLAMER LENS OF A -9.0 DIOPTER TORE/BROKE DURING INJECTION INTO THE PATIENT'S RIGHT EYE (OD) ON (B)(6) 2023. THERE WAS PATIENT CONTACT, BUT NO PATIENT INJURY. CAUSE OF THE EVENT WAS THE DEVICE. REPORTEDLY, "INJECTOR/CARTRIDGE - DEFECTIVE LOT," AND "LENS DEFECT IN PERIPHERY LEAVING UNLESS PATIENT REPORTS PROBLEM & VA PER JLS".
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2185132 | IMPLANTABLE COLLAMER LENS (ICL) | PHAKIC INTRAOCULAR LENS | MTA | STAAR SURGICAL COMPANY | VICM513.2 | NA | 00841542119399 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 22 YR | Female | CARTRIDGE MODEL: LIOLI - LOT# FCK1702| INJECTOR MODEL: LIOLI - LOT# UNK |