FDA Adverse Event
Injury
Summary report: N
VISIAN ICL (IMPLANTABLE COLLAMER LENS)
MDR report key: 2213632
·
Received August 16, 2011
Report
- Report Number
- 2023826-2011-00715
- Event Type
- Injury
- Date Received
- August 16, 2011
- Date of Event
- July 18, 2011
- Report Date
- July 22, 2011
- Manufacturer
- STAAR SURGICAL COMPANY
- Product Code
- HQL
- PMA / PMN Number
- P030016
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- PHYSICIAN ASSISTANT
Narratives
Additional Manufacturer Narrative · 1
(B)(4) - CATARACT, SURGICAL PROCEDURE, SECONDARY, NO PRODUCT ALLEGATION. (B)(4).
Additional Manufacturer Narrative · 1
EVALUATION: METHOD - MEDICAL REVIEW RESULTS: REVIEW OF THIS FILE INDICATES THAT THE NATURAL LENS WAS TOUCHED DURING SURGERY WHICH CAUSED THE CATARACT. TRAUMA TO THE NATURAL LENS IS NOTE AS A TRAUMATIC CATARACT. (B)(4)
Description of Event or Problem · 1
THE REPORTER STATED THE SURGEON INSERTED A MICL13.2 IMPLANTABLE COLLAMER LENS ON (B)(6) 2011 AND AT THIS TIME THE FACILITY WAS OUT OF EPINEPHRINE DROPS, BUT THE SURGEON DECIDED TO PROCEED WITH THE SURGERY. THE PATIENT DEVELOPED A POSTERIOR CATARACT AND THE LENS WAS EXTRACTED ON (B)(6) 2011. THE SURGEON STATED THE INCIDENT WAS THE RESULT OF A CENTRAL LENS TOUCH DURING THE INITIAL IMPLANTATION OF THE LENS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | VISIAN ICL (IMPLANTABLE COLLAMER LENS) | INTRAOCULAR LENS | HQL | STAAR SURGICAL COMPANY | MICL13.2 | N/A |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 46 YR | Required Intervention | FOAM TIP PLUNGER: MODEL, LOT NUMBER UNKNOWN| CARTRIDGE: MODEL SFC-45FP, LOT NUMBER UNKNOWN| INJECTOR: MODEL MSI-PF, LOT NUMBER UNKNOWN |