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

Model Number ZCB00

Device Problem Inadequacy of Device Shape and/or Size (1583)

Patient Problems Visual Impairment (2138); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

Date of event: unknown, not provided, but the best estimate date is during 2017.(b)(4).All pertinent information available to abbott medical optics has been submitted.

Event Description

It was reported that a monofocal intraocular lens (iol), model zcb00 23.5 diopter was explanted from the right eye (od) of a female patient due to the myopic outcome.The patient reported interference with activities of daily living (adls) as she is unable to drive, cannot read road signs, and had difficulty in reading.The lens was replaced with the same model lens of a lower diopter (17.0).There was no patient injury or complications reported.No further information was provided.

Manufacturer Narrative

Device evaluation: the product testing could not be performed as the complaint device was not returned.The reported complaint cannot be confirmed.Manufacturing record review: the manufacturing process record was evaluated and no deviation was found during process related to the complaint issue reported.There was no discrepancy found during the mrr (manufacturing record review).The product was manufactured and released according to the specifications.Labeling review: the directions for use (dfu) was reviewed.The dfu adequately provides instructions and precautions for the proper use and handling of the product.Conclusion: based on the investigation results there is no indication of a product quality deficiency.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.

Manufacturer Narrative

Device available for evaluation? yes.Returned to manufacturer on: 02/02/2018.Device returned to manufacturer? yes.Device evaluation: the lens was received cut in two (2) pieces with one (1) haptic detached.The condition of returned lens could be due to the removal and replacement process.Based on the condition of the lens, the reported complaint could not be confirmed and no product deficiency could be identified.Furthermore, the miq (measurement intraocular lens quality) results were also reviewed and the diopter result for this serial number is within specification, which is measured as 23.63d.The reported complaint cannot be confirmed.Manufacturing record review: manufacturing record review of the production order and related document revealed that the product was manufactured and released according to specification.There was no discrepancy found during the review.A search revealed no additional investigations requested for this production order.Labeling review: the dfu was reviewed.The dfu adequately provides instructions and precautions for the proper use and handling of the product.Conclusion: based on the investigation results there is no indication of a product quality deficiency.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.

• Brand Name: TECNIS 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: 7202587
• MDR Text Key: 97628435
• Report Number: 2648035-2018-00137
• Device Sequence Number: 1
• Product Code: HQL
• UDI-Device Identifier: 05050474531789
• UDI-Public: (01)05050474531789(17)210505
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P980040
• 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,Followup
• Report Date: 06/20/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/17/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Expiration Date: 05/05/2021
• Device Model Number: ZCB00
• Device Catalogue Number: ZCB0000235
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/02/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/24/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/05/2017
• 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: 66 YR