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

Model Number ZCB00V

Device Problem Bent (1059)

Patient Problem No Code Available (3191)

Event Date 01/11/2018

Event Type  Injury  

Manufacturer Narrative

The lens was inserted and removed.(b)(6).This report is being filed on an international device; tecnis optiblue 1-piece iol, that has a similar device, tecnis 1-piece iol model zcb00 which is distributed in the united states under pma p980040 patient code (b)(4)¿ incision enlargement.Device evaluation: the intraocular lens (iol) was returned at the manufacturing site for evaluation.Visual inspection at 10x microscope magnification showed loose fibers/particles and residue of lubricant material were observed on the lens related the handling of the unit out of a sterile environment.One of the haptic was observed detached.The detached haptic piece was not returned.No damage was observed on the other haptic.The conditions of the product returned is consistent with a unit that has been previously handled and prepared for surgical process.The customer''s reported complaint for haptic distorted was not verified.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 investigation requests 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 and the reported issue could not be verified.All pertinent information available to abbott medical optics has been submitted.

Event Description

It was reported that the haptic of an intraocular lens (iol) was distorted after insertion into the patient's eyes.Reportedly, the initial incision of 3.0 mm was enlarged to about 6.0 mm to remove the lens.A back-up lens (same model) was implanted as a replacement.The surgery time was extended.No vitrectomy was performed.The patient had no inflammation or problems.No further information was provided.

• Brand Name: TECNIS OPTIBLUE 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: 7278906
• MDR Text Key: 100389117
• Report Number: 2648035-2018-00255
• Device Sequence Number: 1
• Product Code: HQL
• UDI-Device Identifier: 05050474546714
• UDI-Public: (01)05050474546714(17)221031
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Pharmacist
• Type of Report: Initial
• Report Date: 02/16/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/16/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 10/31/2022
• Device Model Number: ZCB00V
• Device Catalogue Number: ZCB00V0185
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/01/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/23/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/31/2017
• 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: 72 YR