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

Model Number DFR00V

Device Problems Device Difficult to Setup or Prepare (1487); Device Contaminated During Manufacture or Shipping (2969)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/04/2021

Event Type  Injury  

Event Description

Doctor reported that the simplicity delivery system felt tight while inserting in the patient's operative eye.Once inserted, the intraocular lens (iol) had a black material on the optical zone that could not be removed.The doctor had to extend the incision, cut the lens in half and remove it.A back up lens was available to complete the surgery.Three (3) stitches were placed to close the wound.This incident extended surgery time by approximately 40 minutes.Reportedly, no further information is available.

Manufacturer Narrative

If implanted, give date: not applicable, as lens was removed/replaced in the initial surgery.If explanted, give date: not applicable, as lens was removed/replaced in the initial surgery.The intraocular lens (iol) was not returned for evaluation; therefore, a failure analysis of the complaint device cannot be completed.A review of the device history record, 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.An attempt has been made to obtain the missing information; however, no response has been received.All pertinent information available to johnson & johnson surgical vision, inc., has been submitted.

Manufacturer Narrative

Additional information section d9: device available for evaluation? yes.Section d9: date returned to manufacturer: dec 20, 2021.Section h3: evaluated by manufacturer: yes.Device evaluation: visual inspection under magnification revealed that the lens was received with a cut to the optic body, which is consistent with a lens that was handled during removal.The optic body was inspected and no particles could be found on the optic body.However, a loose particle was identified on one of the haptics.An external investigation is required to further analyze this issue.External testing revealed the substance on the haptic of the complaint lens contained fe, cr, ni and al indicating an alloy steel.Low levels of na and cl were also present indicating the presence of a salt species possibly from exposure to a salt solution.While the presence of c and o is significant, it is likely due to the iol background and not related to the foreign material.Due to ftir (fourier transform infrared) being unable to be performed on the foreign material sample, no ftir spectrum could be obtained to be run against the añasco manufacturing process to identify potential sources of the foreign material.The complaint issue foreign material loose was confirmed; however the particle cannot be confirmed to be related to a manufacturing issue due to the handling of the complaint lens during explant and because añasco has manufacturing controls in place to prevent the release of product with foreign material on it.Therefore, no product deficiency could be identified.Manufacturing record review: the manufacturing records for the product were reviewed.The product was manufactured and released according to specifications.A search revealed three complaints that are not related.Therefore, no escalations are required.Conclusion: 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 johnson & johnson surgical vision, inc.Has been submitted.

• 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: 12921625
• MDR Text Key: 284646413
• Report Number: 2020664-2021-08091
• Device Sequence Number: 1
• Product Code: HQL
• UDI-Device Identifier: 05050474750715
• UDI-Public: (01)05050474750715(17)240420
• 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 Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/11/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/02/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: DFR00V
• Device Catalogue Number: DFR00VU220
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/11/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/19/2021
• 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 Sex: Female