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

Model Number Z9002

Device Problems Bent (1059); Break (1069); Crack (1135)

Patient Problem No Code Available (3191)

Event Date 01/30/2017

Event Type  Injury  

Manufacturer Narrative

The lens was inserted and removed.(b)(4).All pertinent information available to the manufacturer has been submitted.

Event Description

It was reported that after insertion of a z9002 28.0 diopter intraocular lens (iol) into the left eye of a patient, it was observed that the lens appeared cracked by the haptics (both pieces/sides).In addition it was indicated the haptic was bent/broken.The lens was removed, the incision was enlarged, a 10.0 nylon suture was used to close the wound.It is noted that the patient has recovered.

Manufacturer Narrative

Device available for evaluation? yes, returned to manufacturer on 3/21/2017.Device returned to manufacturer? yes.Device evaluation: visual inspection at 10x microscope magnification was performed.Fibers/particles were observed on the lens which is related to the handling of the unit out of a non-sterile environment.Residue of viscoelastic were also observed on lens pieces which indicates that the unit was handled and prepared for surgical use.The lens was returned cut in two pieces.One of the haptics was observed distorted.The reported issue was 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.

• Brand Name: TECNIS CL
• 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: 6405068
• MDR Text Key: 69946054
• Report Number: 2648035-2017-00486
• Device Sequence Number: 1
• Product Code: HQL
• UDI-Device Identifier: 05050474530850
• UDI-Public: (01)05050474530850(17)201103
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P880081
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/17/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/15/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 11/03/2020
• Device Model Number: Z9002
• Device Catalogue Number: Z900200280
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/21/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/22/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/03/2015
• 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
• Patient Age: 78 YR