MAUDE Adverse Event Report: ABBOTT MEDICAL OPTICS TECNIS ITEC PRELOADED 1-PIECE IOL; MONOFOCAL IOLS

Model Number PCB00

Device Problem Sticking (1597)

Patient Problems Corneal Decompensation (1790); Clouding, Central Corneal (2228); Capsular Bag Tear (2639)

Event Date 07/24/2017

Event Type  Injury  

Manufacturer Narrative

Age/date of birth: unknown, information not provided.Gender/sex: unknown, information not provided.If explanted, give date: not applicable, lens remains implanted.(b)(6).Device manufacture date: unknown, information not provided.Device evaluation: the intraocular lens (iol) was not returned to the manufacturing site as it remains implanted.Therefore, product testing could not be performed and the customer¿s reported complaint could not be verified.Manufacturing records review: the manufacturing records for the intraocular lens were reviewed.The product was manufactured and released according to specification.A search on complaints revealed that no other complaints have been received for this production order number.Labeling review: the directions for use (dfu) was reviewed.The 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 when a tecnis itec preloaded 1-piece intraocular lens (iol), model pcb00, was implanted into the operative eye, the legs/haptic failed to release themselves from the optical portion of the lens.It took ten minutes to physically disengage the legs from the optic.This extra manipulation in the eye led to damage to the posterior capsule and the cornea.The physician noted posterior capsule rupture and corneal decompensation (that was hoped to be reversible).The doctor will follow up with the patient and hopes the corneal edema will clear.The lens remains implanted and there was no vitreous prolapse at the time of surgery.Currently the patient has a severe central corneal edema reducing vision down to hand motion (hm).Intraocular pressure (iop) is normal.The eye was not injected excessively.Anterior chamber activity is hard to assess through corneal edema, pupil is round, and posterior chamber intraocular lens (pciol) in situ and appears well centered.It was reported that the cornea is still too cloudy to allow a proper assessment.The patient will be re-assessed in a few weeks.No additional information was provided.

• Brand Name: TECNIS ITEC PRELOADED 1-PIECE IOL
• Type of Device: MONOFOCAL IOLS
• Manufacturer (Section D): ABBOTT MEDICAL OPTICS; santa ana CA 92705
• 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: 6821480
• MDR Text Key: 83675477
• Report Number: 2648035-2017-01550
• Device Sequence Number: 1
• Product Code: HQL
• UDI-Device Identifier: 05050474558281
• UDI-Public: (01)05050474558281(17)200308
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: P980040
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 08/25/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/25/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 03/08/2020
• Device Model Number: PCB00
• Device Catalogue Number: PCB0000210
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/02/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/08/2017
• 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