MAUDE Adverse Event Report: JOHNSON AND JOHNSON SURGICAL VISION, INC. TECNIS ITEC PRELOADED 1-PIECE IOL; MONOFOCAL IOLS

Model Number PCB00

Device Problem Detachment Of Device Component (1104)

Patient Problems Capsular Bag Tear (2639); Vitrectomy (2643); No Code Available (3191)

Event Date 05/22/2018

Event Type  Injury  

Manufacturer Narrative

The intraocular lens was removed and replaced during the same procedure.(b)(4).Device evaluation: it was reported that the product was not available since it was discarded.The complaint reported could not be confirmed.Manufacturing records review: the manufacturing records for the product were reviewed.The product was manufactured and released according to specifications.A search revealed that no additional complaints for this order number have been received.Labeling review: the directions for use (dfu) were reviewed.The dfu provide the customer with proper usage instructions and guidelines.Conclusion: as a result of the investigation, there is no indication of a product quality deficiency.All pertinent information available to johnson and johnson surgical vision, inc.Has been submitted.

Event Description

It was reported that a pcb00 device had a major complication with a shaved off haptic on a preloaded lens in surgery.The customer also noticed some inconsistencies with how the lens comes out.The cartridge and the lens were in contact with the patient¿s left eye.The lens was partially delivered into the patient¿s eye and then removed.Removal and replacement of the lens happened during the same procedure.The procedure was completed successfully with a backup lens.The patient experienced an anterior capsule tear, requiring a vitrectomy.The incision was enlarged and a suture was required.The patient was referred to retina specialist for secondary iol implant and vitrectomy.The patient was doing well when discharged.The lens was discarded.No additional information was provided to johnson and johnson surgical vision, inc.

• Brand Name: TECNIS ITEC PRELOADED 1-PIECE IOL
• Type of Device: MONOFOCAL IOLS
• Manufacturer (Section D): JOHNSON AND JOHNSON SURGICAL VISION, INC.; santa ana CA
• Manufacturer (Section G): JOHNSON AND JOHNSON SURGICAL VISION, INC.; road 402 north, km 4.2; anasco industrial park, pob 14; anasco PR 00610
• Manufacturer Contact: pamela mcclain ; 1700 east st. andrew place; santa ana, CA 92705 ; 7142478243
• MDR Report Key: 7604379
• MDR Text Key: 111138048
• Report Number: 2648035-2018-00875
• Device Sequence Number: 1
• Product Code: HQL
• UDI-Device Identifier: 05050474558281
• UDI-Public: (01)05050474558281(17)210130
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: P980040
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 06/14/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 01/30/2021
• Device Model Number: PCB00
• Device Catalogue Number: PCB0000210
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/22/2018
• Initial Date FDA Received: 06/15/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/30/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 77 YR