MAUDE Adverse Event Report: AMO PUERTO RICO MFG. INC. TECNIS IOL; LENS, INTRAOCULAR, TORIC OPTICS

Model Number DIU150I140

Device Problem Scratched Material (3020)

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

Event Date 07/19/2022

Event Type  malfunction  

Event Description

It was reported that after implantation of the preloaded intraocular lens (iol) the surgeon noticed a mark on the connection of the optical zone and the haptic.The nurse followed the directions for use (dfu) and no interventions were reported.Through follow-up we learned that no explant is planned and that the patient has normal visual acuity after surgery.No further information available.

Manufacturer Narrative

Per regulation eu 2016/679 (general data protection regulation), patient identifiers were not collected or recorded and therefore are not available.Explant date: n/a , lens remains implanted; therefore it was not explanted.Initial reporter name and address: telephone number: (b)(6).The intraocular lens (iol) was not returned for evaluation as it remains implanted.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.All pertinent information available to johnson and johnson surgical vision, inc.Has been submitted.

Manufacturer Narrative

Additional information: device evaluation: the intraocular lens (iol) was not returned for evaluation.However, a photo was provided by the customer and evaluated.This evaluation found a linear mark at the base of the haptic-optic junction which covers approximately 90-95% of the junction.The root cause and potential clinical impact of the observed phenomena could not be determined from a picture assessment.The complaint issue of cosmetic issue was not identified during the photo evaluation.The other observed issues during the photo evaluation could not be confirmed to be related to a manufacturing or design issue.Therefore, there is no indication of a product deficiency or product malfunction.Conclusion: as a result of the investigation, there is no indication of a product quality deficiency.All pertinent information available to johnson and johnson surgical vision, inc.Has been submitted.

• Brand Name: TECNIS IOL
• Type of Device: LENS, INTRAOCULAR, TORIC OPTICS
• Manufacturer (Section D): AMO PUERTO RICO MFG. INC.; road 402 north, anasco ind. pk; anasco PR 00610
• Manufacturer Contact: somyata nagpal ; 31 technology drive; irvine, CA 92618 ; 7142478552
• MDR Report Key: 15229127
• MDR Text Key: 305104521
• Report Number: 3012236936-2022-01957
• Device Sequence Number: 1
• Product Code: MJP
• UDI-Device Identifier: 05050474726307
• UDI-Public: (01)05050474726307(17)250328
• Combination Product (y/n): N
• Reporter Country Code: PO
• PMA/PMN Number: P980040
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 10/24/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/15/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: DIU150I140
• Device Catalogue Number: DIU150I140
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/04/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/28/2022
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1