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

Model Number PCB00

Device Problems Difficult or Delayed Positioning (1157); Device Operates Differently Than Expected (2913)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/09/2018

Event Type  malfunction  

Manufacturer Narrative

If explanted, give date: not applicable as there is no indication that the lens was explanted.(b)(6).The lens remains implanted and the preloaded device is not available for evaluation; therefore a failure analysis of the complaint device cannot be completed.A review of the device history record, labeling, complaint trending, and risk documentation for this device will be performed.Upon completion of the review, if there is any further relevant information a supplemental medwatch will be filed.All pertinent information available to johnson and johnson surgical vision, inc.Has been submitted.

Event Description

It was reported that during the implantation of the intraocular lens (model pcb00), the trailing haptic was not folded on the optic.Reportedly, the lens was partially delivered into the eye and got stuck in the cartridge.With the use of the mcpherson forceps the surgeon was able to pull the haptic out of the inserter and the lens was injected without damage to the eye.The account commented that the preloaded delivery system is not available for inspection.No further information was provided.

• 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: pam mcclain ; 1700 east st. andrew place; santa ana, CA 92705 ; 7142478243
• MDR Report Key: 7497174
• MDR Text Key: 107693364
• Report Number: 2648035-2018-00675
• Device Sequence Number: 1
• Product Code: HQL
• UDI-Device Identifier: 05050474558298
• UDI-Public: (01)05050474558298(17)200505
• Combination Product (y/n): N
• Reporter Country Code: NL
• PMA/PMN Number: P980040
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/08/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 05/05/2020
• Device Model Number: PCB00
• Device Catalogue Number: PCB0000215
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 04/09/2018
• Initial Date FDA Received: 05/08/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/05/2017
• 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