MAUDE Adverse Event Report: ABBOTT MEDICAL OPTICS TECNIS 1-PIECE; MONOFOCAL IOLS

Model Number ZCB00

Device Problems Difficult or Delayed Positioning (1157); Difficult to Insert (1316)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/24/2017

Event Type  malfunction  

Manufacturer Narrative

Age/date of birth: unknown, not provided.Gender/sex: unknown/not provided.The lens was not implanted and therefore not explanted.All pertinent information available to the manufacturer has been submitted.

Event Description

It was reported that the during implantation of a zcb00 intraocular lens (iol), the lens would not come out of the lens unfolder once it had been placed into the patient's eye.It was indicated that the lens was loaded into a disposable unfolder by the physician.When the physician tried to release the lens into the eye it would not come out of the unfolder.The lens was in contact with the patient but there was no patient issues.The lens was discarded.The physician opened another lens but used the same unfolder.The lens was released into the eye with no issues.

Manufacturer Narrative

Corrected data: in the initial mdr section method codes, result code and conclusion codes were entered for device evaluation however comments were inadvertently not included.Additional conclusion code of (b)(4) is being added and the following comments are now being provided.Device evaluation: product testing could not be performed since no product was returned for evaluation.According to the initial report the lens was discarded by the customer.Therefore, the reported issue could not be verified.Manufacturing record review: manufacturing record review of the production order and related document revealed that the product was manufactured and released according to specification.A search on complaints revealed that no other complaint was received from this production order.Labeling review: a review of the directions for use was conducted.The dfu adequately provides instructions and precautions for the proper use and handling of the device.All pertinent information available to the manufacturer has been submitted.

• Brand Name: TECNIS 1-PIECE
• Type of Device: MONOFOCAL IOLS
• Manufacturer (Section D): ABBOTT MEDICAL OPTICS; santa ana CA
• Manufacturer (Section G): ABBOTT MEDICAL OPTICS 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: 6513749
• MDR Text Key: 73456230
• Report Number: 2648035-2017-00718
• Device Sequence Number: 1
• Product Code: HQL
• UDI-Device Identifier: 05050474531680
• UDI-Public: (01)05050474531680(17)200428
• 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: foreign,health professional,u
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 04/21/2017

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: 04/28/2020
• Device Model Number: ZCB00
• Device Catalogue Number: ZCB0000185
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 04/20/2017
• Initial Date FDA Received: 04/22/2017
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 04/22/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/28/2016
• 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