TECNIS

Report

Report Number: 2648035-2018-00508
Event Type: Injury
Date Received: April 12, 2018
Date of Event: January 19, 2018
Report Date: July 4, 2018
Manufacturer: JOHNSON & JOHNSON SURGICAL VISION, INC.
Product Code: HQL
PMA / PMN Number: P990080
Adverse Event: Yes
Product Problem: Yes
Report Source: Manufacturer report
Reporter Occupation: PHYSICIAN

Narratives

Additional Manufacturer Narrative · 1

ADDITIONAL INFORMATION RECEIVED INDICATED THAT THE CAUSE OF THE HOLE IN THE BACK OF THE PATIENT¿S CAPSULE WAS AN EARLY VITRECTOMY. IT WAS CONFIRMED THAT JOHNSON AND JOHNSON SURGICAL VISION PHACO SYSTEM OR LENS WAS NOT INVOLVED OR CAUSED THE HOLE IN THE PATIENT'S CAPSULE. IT WAS NOTED THAT THE IOL WAS DISPLACED BECAUSE THE HAPTIC WAS BROKEN IN HALF, IT WAS NOT DETACHED. IT WAS REPORTED THAT THERE WAS AN INCISION ENLARGEMENT PERFORMED; HOWEVER, NO SUTURE WAS USED AND NO VITRECTOMY WAS REQUIRED. THE FOLLOWING FIELDS WERE UPDATED BASED ON THE RECEIVED INFORMATION: BRAND NAME: TECNIS. MODEL#: ZA9003. SERIAL#: (B)(4). CATALOG#: ZA90030190. EXPIRATION DATE: 8/23/2018. UDI #: (B)(4). PMA: P990080. DEVICE MANUFACTURE DATE: 8/23/2013. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON AND JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

Additional Manufacturer Narrative · 1

DEVICE AVAILABLE FOR EVALUATION? YES. RETURNED TO MANUFACTURER ON: 06/06/2018. DEVICE RETURNED TO MANUFACTURER? YES. DEVICE EVALUATION: THE INTRAOCULAR LENS (IOL) WAS RETURNED AT THE MANUFACTURING SITE FOR EVALUATION. VISUAL INSPECTION UNDER THE MICROSCOPE SHOWED THAT ONE HAPTIC WAS DETACHED. THE OTHER HAPTIC WAS OBSERVED DISTORTED/BENT. THE CONDITION OBSERVED IN THE UNIT WAS CONSISTENT WITH A LENS THAT WAS HANDLED FOR SURGICAL USE. THE CUSTOMER'S REPORTED COMPLAINT FOR HAPTIC BROKEN WAS VERIFIED; HOWEVER THERE IS NO EVIDENCE TO SUGGEST THAT THE COMPLAINT SAMPLE HAS BEEN AFFECTED BY THE MANUFACTURING PROCESS. NO PRODUCT DEFICIENCY WAS IDENTIFIED. MANUFACTURING RECORDS REVIEW: THE MANUFACTURING RECORDS FOR THE INTRAOCULAR LENS WERE REVIEWED. THE PRODUCT WAS MANUFACTURED AND RELEASED ACCORDING TO SPECIFICATION. A SEARCH REVEALED THAT NO ADDITIONAL COMPLAINTS FOR THIS ORDER NUMBER HAVE BEEN RECEIVED. LABELING REVIEW: THE DIRECTIONS FOR USE (DFU) ADEQUATELY PROVIDES INSTRUCTIONS AND PRECAUTIONS ALONG WITH WARNINGS FOR THE PROPER USE AND HANDLING OF THE DEVICE. THE DFU STATES TO EXAMINE THE LENS THOROUGHLY TO ENSURE PARTICLES HAVE NOT BECOME ATTACHED TO IT, AND EXAMINE THE LENS OPTICAL SURFACES FOR OTHER DEFECTS. AS A RESULT OF THE INVESTIGATION THERE IS NO INDICATION OF A PRODUCT QUALITY DEFICIENCY AND THE REPORTED ISSUE WAS VERIFIED. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON AND JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

Additional Manufacturer Narrative · 1

(B)(6). (B)(4). DEVICE MANUFACTURE DATE: UNKNOWN AS PRODUCT SERIAL NUMBER WAS NOT PROVIDED. ATTEMPTS HAVE BEEN MADE TO OBTAIN MISSING INFORMATION; HOWEVER, TO DATE, NO RESPONSE HAS BEEN RECEIVED. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON AND JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

Description of Event or Problem · 1

IT WAS REPORTED THAT AN AN INTRAOCULAR LENS (IOL) WAS EXPLANTED FROM A MALE PATIENT¿S OPERATIVE EYE AS ONE (1) OF THE HAPTICS WAS OBSERVED TO BE BROKEN THE DAY AFTER THE IMPLANT. REPORTEDLY, THE IOL HAD BECOME DISPLACED AND THE PATIENT WAS SUFFERING FROM POOR VISION. THE PATIENT WAS OPERATED TO IMPLANT THE IOL IN THE SULCUS AS THERE WAS A KNOWN HOLE IN THE BACK OF THE PATIENT'S CAPSULE BEFORE THE CATARACT SURGERY. NO ADDITIONAL INFORMATION WAS PROVIDED.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
269886	TECNIS	MONOFOCAL IOLS	HQL	JOHNSON & JOHNSON SURGICAL VISION, INC.	ZA9003

Patients

Seq	Age	Sex	Outcome	Treatment
1	67 YR		Required Intervention