MAUDE Adverse Event Report: AMO MANUFACTURING NETHERLANDS TECNIS IOL; INTRAOCULAR LENS

Model Number ZCW300

Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)

Patient Problems Visual Impairment (2138); Swelling/ Edema (4577)

Event Date 08/25/2021

Event Type  Injury  

Manufacturer Narrative

If implanted, give date: unknown, information not provided.If explanted, give date: not applicable as the lens remains implanted reporter first & last name: unknown, not provided.(b)(6).The device is not returning for evaluation as to date it remains implanted; therefore, a failure analysis of the complaint device cannot be completed.A review of the device history record, labeling, complaint trending, and risk documentation for this device will be performed.Upon completion of the review, if there is any further relevant information a supplemental medwatch will be filed.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.

Event Description

It was reported that the degree of astigmatism of a patient implanted with an intraocular lens (iol) doubled even though the patient did not use contact lenses or have irregular astigmatism and a preoperative exam on (b)(6) 2021 revealed there was no deviation of axis.Internal astigmatism of the lens is to be checked with casia2 (tomey, cornea/ anterior segment oct) at an academic medical center even though the lens remains implanted.If the axis of internal astigmatism is different, the doctor will plan to remove the iol or changing the degree of the axis by 90 degrees will be considered as a treatment.It was indicated that the data that the doctor entered were accurate.Therefore, it could be a quality problem (dotline of the iol was steep meridian).The lens remains implanted.On the evening of (b)(6) 2021, the doctor examined the eye again and there was a slightly whitened part in the entire cornea.When checking the corneal data, it seems that the ring has a distorted shape.As a result, the doctor came to the conclusion that corneal edema is the cause at this time.When the edema improves by an eye drop, the data of total astigmatism after surgery will be performed again.Before the operation, the naked eye was about 0.2, and after the operation, the naked eye is 0.2 and the corrected visual acuity is 0.3.Regarding the inspection equipment, it is said that refcare was recently repaired, so the preoperative corneal data and postoperative total astigmatism are the data after repair.The preoperative corneal astigmatism is -2.25 diopter ax81, and the postoperative total astigmatism is -4.75 ax43.The axis was calculated out by the anterior segment photography method.It was confirmed by mydriasis after the operation, but there was no rotation and doctor commented that it was not the cause of this problem.It was indicated that it is possible to confirm internal astigmatism of the lens with casia2 (advance) and the doctor is planning to request and measure it by himself.It was confirmed that the patient was treated with eye drops (instillation) to cure edema.No further information was provided.

• Brand Name: TECNIS IOL
• Type of Device: INTRAOCULAR LENS
• Manufacturer (Section D): AMO MANUFACTURING NETHERLANDS; van swietenlaan 5; groningen, groningen 9728 NX; NL 9728 NX
• Manufacturer Contact: somyata nagpal ; 1700 e st andrew place; santa ana, CA 92705 ; 7142478552
• MDR Report Key: 12517048
• MDR Text Key: 272898669
• Report Number: 2020664-2021-07495
• Device Sequence Number: 1
• Product Code: HQL
• UDI-Device Identifier: 05050474699380
• UDI-Public: (01)05050474699380(17)250213
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: P980040
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 09/22/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/22/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: ZCW300
• Device Catalogue Number: ZCW300I200
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/26/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/13/2020
• 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: 74 YR