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

Catalog Number DFR00VI085

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

Patient Problem Visual Impairment (2138)

Event Type  Injury  

Manufacturer Narrative

Weight, ethnicity: information unknown/not provided.Date of event: the exact date of event is unknown, not provided, but the best estimate date is prior to (b)(6) 2021.Reporter first & last name: unknown, not provided.Phone number: (b)(6) phone number: (b)(6).The device is not returning for evaluation as it was discarded; 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 & johnson surgical vision, inc.Has been submitted.

Event Description

It was reported that an intraocular lens (iol) was explanted from a patient's left eye as the patient had become more near-sighted/myopic.That the patient did not get the expected eyesight, -1d to 1.5d compare to before the surgery.The postoperative refraction value is s-2.0 c-0.75 and target postoperative refraction +0.1, expected visual acuity 1.0 or more with the naked eye.The patient is satisfied with naked eye vision after replacement with best corrected visual acuity (bcva) after surgery: 1.0, naked eye distant 0.5.There was no interventions required and no problem after lens replacement was reported.It was noted that the lens will not be returning as it was discarded.No further information was provided.

• Brand Name: TECNIS SYNERGY SIMPLICITY
• 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 ; van swietenlaan 5; groningen, groningen 9728 -NX ; NL 9728 NX
• MDR Report Key: 12164612
• MDR Text Key: 261449035
• Report Number: 9614546-2021-07274
• Device Sequence Number: 1
• Product Code: HQL
• UDI-Device Identifier: 05050474709645
• UDI-Public: (01)05050474709645(17)231217
• 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: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 07/13/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/14/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/17/2023
• Device Catalogue Number: DFR00VI085
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/22/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/17/2020
• 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: 57 YR