FDA Adverse Event Injury Summary report: N

INTRALASE PATIENT INTERFACE

MDR report key: 2243800 · Received September 1, 2011

Report

Report Number: 2648035-2011-00199
Event Type: Injury
Date Received: September 1, 2011
Date of Event: July 29, 2011
Report Date: August 4, 2011
Manufacturer: ABBOTT MEDICAL OPTICS
Product Code: HNO
PMA / PMN Number: K060372
Report Source: Manufacturer report
Reporter Location: CH
Reporter Occupation: NOT APPLICABLE

Narratives

Additional Manufacturer Narrative · 1

(B)(4). DEVICE IS GOING TO BE INVESTIGATED HOWEVER, IT HAS NOT BEEN REACHED YET. METHOD: NOT AVAILABLE AT THE TIME OF THIS REPORT. RESULTS: NOT AVAILABLE AT THE TIME OF THIS REPORT. CONCLUSION: AT THE TIME OF THIS REPORT THE DEVICE HAS NOT BEEN RECEIVED FOR EVAL. (B)(4) VISITED SITE TO CHECK LASER EQUIPMENT THAT WAS USED WITH THE PT INTERFACE (LASER (B)(4)) AND CONFIRMED THE EQUIPMENT WAS IN GOOD CONDITION. (B)(4) VISITED THE SITE TO REVIEW THE SITUATION WITH PHYSICIAN (PI CONDITION, THE CUSTOMER STERILIZING TECHNIQUE AND CLEANING PRACTICE, GLOVE USAGE AND THE OPERATION ROOM CONDITIONS) BUT NO ISSUES WERE NOTED. NOTE: ALL PERTINENT INFO AVAILABLE TO ABBOTT MEDICAL OPTICS (AMO) AT THE TIME OF THIS REPORT HAS BEEN SUBMITTED. SHOULD NEW INFO THAT CHANGES THE FACTS AND/OR CONCLUSION OF THIS REPORT BECOMES AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

Description of Event or Problem · 1

ACCOUNT REPORTED THAT (B)(6) POST-OPERATION ON (B)(6) 2011 PT PRESENTED WITH DLK STAGE III. FLAP WAS LIFTED AND RINSE ON (B)(6) 2011. DLK RESOLVED ON (B)(6) 2011. PRE-OP BCVA (DECIMAL): OD 1.0, OS 1.0. POST-OP UCVA (B)(6) (DECIMAL): OD 0.8, OS 1.0. POST-OP UCVA FINAL (DECIMAL): OD 1.0, OS 1.0.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	INTRALASE PATIENT INTERFACE		HNO	ABBOTT MEDICAL OPTICS		CJ00251

Patients

Seq	Age	Sex	Outcome	Treatment
1	33 YR		Required Intervention	(B)(4)\| FEMTOSECOND LASER: MODEL R20005K,