MAUDE Adverse Event Report: AMO PUERTO RICO MFG. INC. TECNIS SIMPLICITY; INTRAOCULAR LENS

Model Number DIB00V

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Flashers (1864); Halo (2227); Discomfort (2330)

Event Type  Injury  

Event Description

It was reported that a patient complained about an intraocular lens (iol) in their left eye, that their entire vision is poor, peripheral area near the ear seems whitish, that they see halo.The patient was relatively younger and their preoperative corrected vision was not bad.It was indicated that the patient has a nervous personality and is short-tempered and complained from day 4 post surgery.It was also stated that since the patient's expectations were high for informed consent in pre-operative, they commented that the complaint was from the patient's subjectivity.The left eye astigmatism reported to be 0.75d.The modulation transfer function (mtf) value of the left eye did not improved compared with the preoperative value which the doctor was thinking it could be a cause.A lens exchange was being considered and they were taking a wait-and-see approach.Additional information indicated that the lens was later explanted.The product is not available for returned.No further information was provided.

Manufacturer Narrative

Patient age and weight: information unknown/ asked but was not provided.Date of event: unknown, not provided, but the best estimate date is (b)(6) 2022.If explanted, give date: unknown, the information was not provided.Initial reporter phone number: (b)(6).This report is being filed on an international device; tecnis eyhance optiblue simplicity, model dib00v that has a similar device, tecnis simplicity tecnis eyhance iol model dib00 which is distributed in the unites states under pma p980040.The device was not returned for analysis.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.Attempts have been made to obtain missing information; however, to date, the information has not been received.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.

• Brand Name: TECNIS SIMPLICITY
• Type of Device: INTRAOCULAR LENS
• 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: 15057974
• MDR Text Key: 296213835
• Report Number: 3012236936-2022-01915
• Device Sequence Number: 1
• Product Code: HQL
• UDI-Device Identifier: 05050474739536
• UDI-Public: (01)05050474739536(17)241029
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 07/19/2022

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: Health Professional
• Device Model Number: DIB00V
• Device Catalogue Number: DIB00VI235
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 06/23/2022
• Initial Date FDA Received: 07/19/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/29/2021
• 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 Ethnicity: Non Hispanic
• Patient Race: Asian