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

Model Number ZA9003

Device Problems Difficult or Delayed Positioning (1157); Premature Activation (1484); Appropriate Term/Code Not Available (3191)

Patient Problems Glaucoma (1875); Hyphema (1911); Vitrectomy (2643); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

(b)(4).(b)(6).(b)(4).All pertinent information available to abbott medical optics has been submitted.

Event Description

It was reported that during preparation of the intraocular lens, the doctor used a non amo cartridge.At the implant moment, the lens opened too fast in the patient's eye.There was a delay in the surgery, about one and a half hours.The patient presented with hyphema and glaucoma, and it was necessary to perform a vitrectomy.The patient was monitored after it happened, and now the patient is getting better.No further information was provided.

Manufacturer Narrative

Visual inspection was not performed as the lens has not been returned to the manufacturer.The reported complaint cannot be confirmed.Manufacturing records were reviewed and the lens was manufactured according to specification.There were no non-conformances generated and no issues reported during the manufacturing process.A search on complaints revealed no other complaints were received for this order number to date.The directions for use (dfu) was reviewed.The dfu adequately provides instructions and precautions for the proper use and handling of the intraocular lenses.It clearly indicates that the unfolded emeraldt or emeraldxl implantation series should be used.Also included in the instructions are how to fold the lens if using forceps.All pertinent information available to abbott medical optics has been submitted.

• Brand Name: TECNIS
• 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: 5147932
• MDR Text Key: 28199205
• Report Number: 2648035-2015-00953
• Device Sequence Number: 1
• Product Code: HQL
• Combination Product (y/n): N
• Reporter Country Code: BR
• PMA/PMN Number: P990080
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Physician
• Type of Report: Followup
• Report Date: 02/25/2016

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: 07/04/2018
• Device Model Number: ZA9003
• Device Catalogue Number: ZA90030255
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/14/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 02/25/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/04/2013
• 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