MAUDE Adverse Event Report: JOHNSON AND JOHNSON SURGICAL VISION, INC. TECNIS; TORIC IOLS

Model Number ZCT150

Device Problems Difficult or Delayed Positioning (1157); Device Handling Problem (3265)

Patient Problems Corneal Abrasion (1789); Visual Disturbances (2140); No Code Available (3191)

Event Date 03/01/2018

Event Type  Injury  

Manufacturer Narrative

Date of birth: unknown, not provided.Sex/gender: unknown, not provided.Serial #: unknown/not provided.Expiration date: unknown since serial number was not provided.Udi #: unknown since serial number was not provided.If implanted, give date: not applicable as the lens was not implanted.If explanted, give date: not applicable as the lens was not implanted and therefore not explanted.Concomitant medical products: competitor cartridge and injector.(b)(6).Manufacturing date: unknown since serial number was not provided.(b)(4).Attempts have been made to obtain missing information; however, to date, no response has been received.The device was not returned for analysis as it was discarded by the customer.The serial number is not available; therefore, no further investigation can be performed.If there is any further relevant information received, 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 implantation, the intraocular lens (model zct150 + 24.5 diopter) felt ¿tight¿ going through his regular 2.2mm incision in the patient's eye.Reportedly, the wound was enlarged to 2.6mm but it was noted that the lens still felt ¿tight¿ moving through the wound.The lens was not used and discarded.It was also reported that as the lens was advanced through the corneal incision, rather than moving posteriorly and into the capsular bag, it headed upwards into the sub-descemets plane resulting in a corneal abrasion as the lens moved past the posterior corneal surface.Subsequently, the surgeon noted that this resulted in significant visual changes to the patient post operatively.The surgeon commented that the lens was loaded correctly by the theatre staff, and the lens was folded in the correct orientation.The account also commented that they used a non johnson & johnson cartridge and injector (non-approved and non-validated delivery system).No further information was provided.

• Brand Name: TECNIS
• Type of Device: TORIC IOLS
• Manufacturer (Section D): JOHNSON AND JOHNSON SURGICAL VISION, INC.; santa ana CA
• Manufacturer (Section G): JOHNSON AND JOHNSON SURGICAL VISION, INC.; van swietenlaan 5; groningen 9728 NX; NL 9728 NX
• Manufacturer Contact: pam mcclain ; 1700 east st. andrew place; santa ana, CA 92705 ; 7142478243
• MDR Report Key: 7431652
• MDR Text Key: 105514304
• Report Number: 9614546-2018-00350
• Device Sequence Number: 1
• Product Code: HQL
• UDI-Public: (01)
• Combination Product (y/n): N
• Reporter Country Code: AU
• 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: 04/14/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/14/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Model Number: ZCT150
• Device Catalogue Number: ZCT1500245
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/16/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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): Other