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

Model Number Z9002

Device Problem Bent (1059)

Patient Problems No Patient Involvement (2645); No Information (3190)

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that an intraocular lens (iol) had a bent haptic.No further information was provided.

Manufacturer Narrative

Additional information/corrected data: additional information was received and it was learnt there was no patient contact and no patient injury.The haptic was bent before insertion into the eye.This event has now been determined not to be a reportable event.(b)(4).Device available for evaluation? yes.Returned to manufacturer on: 08/03/2017.Device returned to manufacturer? yes.Device evaluation: the intraocular lens (iol) was returned at the manufacturing site for evaluation.Visual inspection showed that the lens had viscoelastic residue.Slight marks were observed.One haptic was observed bent and the other was observed positioned.The customer's reported complaint was verified however based on the condition of the sample, the issue could not be related to the manufacturing process.Manufacturing records review: the manufacturing records for the intraocular lens were reviewed.The product was manufactured and released according to specification.A search revealed that no additional complaints for this order number have been received.Labeling review: the directions for use (dfu) were reviewed.The directions for use (dfu) adequately provides instructions and precautions along with warnings for the proper use and handling of the device.As a result of the investigation there is no indication of a product quality deficiency.No further reports will be submitted for this event.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: 6759348
• MDR Text Key: 81588127
• Report Number: 2648035-2017-01417
• Device Sequence Number: 1
• Product Code: HQL
• UDI-Device Identifier: 05050474530546
• UDI-Public: (01)05050474530546(17)211115
• 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: Other
• Type of Report: Initial,Followup
• Report Date: 08/23/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/02/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 11/15/2021
• Device Model Number: Z9002
• Device Catalogue Number: Z900200125
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/03/2017
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/01/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/15/2016
• 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