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

Model Number ZA9003

Device Problems Difficult to Fold, Unfold or Collapse (1254); Kinked (1339)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

Age/date of birth: unknown/ not provided.Sex/gender: unknown/ not provided.Date of event: unknown/not provided.If implanted; give date: n/a (not applicable).The intraocular lens was removed and replaced during the same procedure.If explanted; give date: n/a (not applicable).The intraocular lens was removed and replaced during the same procedure.Device evaluation: the product was not returned; therefore, the reported issue was not verified 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 adequately provide instructions and precautions along with warnings for the proper use and handling of the device.Conclusion: as a result of the investigation, there is no indication of a product quality deficiency.All pertinent information available to abbott medical optics has been submitted.

Event Description

According to the surgeon, the intraocular lens (iol) had a crease in its center when it unfolded.The surgeon loaded the iol and began to insert it into the eye.As the lens was unfolding inside the eye, he could see that it didn't look right under the microscope.It was stated that the iol had a crease in it and was not unfolding correctly.The iol was removed and replaced with a different one during the same procedure.The incision did not have to be enlarged.The patient was not injured.The patient is doing fine.No additional information was provided to abbott medical optics.

• 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: pamela mcclain ; 1700 east st. andrew place; santa ana, CA 92705 ; 7142478243
• MDR Report Key: 6333267
• MDR Text Key: 67595660
• Report Number: 2648035-2017-00303
• Device Sequence Number: 1
• Product Code: HQL
• UDI-Device Identifier: 05050474528925
• UDI-Public: (01)05050474528925(17)180801
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P990080
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/15/2017

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: 08/01/2018
• Device Model Number: ZA9003
• Device Catalogue Number: ZA90030155
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 01/19/2017
• Initial Date FDA Received: 02/15/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/01/2013
• 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
• Treatment: EMERALDC30, LOT CB39363