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

Model Number UNKNOWN

Device Problem Migration or Expulsion of Device (1395)

Patient Problems Corneal Abrasion (1789); Corneal Perforation (1792); No Code Available (3191)

Event Date 04/21/2017

Event Type  Injury  

Manufacturer Narrative

The serial number was not provided common device name: monofocal has been entered; however, the exact lens type was not provided.Procode: hql entered; however, the exact lens type was not provided.The lens remains implanted.(b)(6) (b)(4).Attempts have been made to obtain missing information; however, to date, no response has been received.All pertinent information available to abbott medical optics has been submitted.

Event Description

It was reported that a large corneal abrasion was diagnosed in the right eye (od) 1 day after surgery, following a catalyst procedure on (b)(6) 2017 with no complications reported.The corneal abrasion led to a corneal melt and a subluxation and perforation in the days following the surgery.Two weeks post-operatively, the doctor was informed that the patient had been seen by a hospital ophthalmologist due to decreased vision 5 days after surgery.The hospital noted a malformation in the patient's cornea inferiorly.The lens remains implanted in the eye.Pre-operatively the patient's uncorrected visual acuity (ucva) od was 0.4.Post-operatively, the patient only sees hand movement and the expected recovery time is 1 year.Histoacrylic glue was used during a procedure on (b)(6) 2017, and a localized corneal transplant, iol repositioning, and amnion membrane procedure was carried out on (b)(6) 2017.No additional information was provided.

Manufacturer Narrative

Device evaluation: the product 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 record cannot be reviewed since the serial number is unknown.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.

• Brand Name: UNKNOWN
• 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: 6881723
• MDR Text Key: 86831170
• Report Number: 2648035-2017-01685
• Device Sequence Number: 1
• Product Code: HQL
• UDI-Public: (01)
• Combination Product (y/n): N
• 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,Followup
• Report Date: 02/07/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Model Number: UNKNOWN
• Device Catalogue Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/28/2017
• Initial Date FDA Received: 09/20/2017
• Supplement Dates Manufacturer Received: 01/11/2018
• Supplement Dates FDA Received: 02/07/2018
• Was Device Evaluated by Manufacturer?: Yes
• 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: 67 YR