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

Model Number DIB00

Device Problem Inaccurate Delivery (2339)

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

Event Date 04/26/2023

Event Type  malfunction  

Manufacturer Narrative

Patient information cannot be provided due to personal data privacy legislation/policy.Section d6a: implant date: not applicable, as lens was removed/replaced in the initial surgery.Explant date: not applicable, as lens was removed/replaced in the initial surgery.Initial reporter email address: unknown/not provided.Initial reporter telephone number: (b)(6).Device evaluation: the product testing could not be performed as the product was not returned.The reported complaint cannot be confirmed.Manufacturing record evaluation: based on the manufacturing records review, and historical complaint review, there is no indication of a product malfunction or product quality deficiency.No nonconformity report, documentation or labeling changes, and escalations are required.Conclusion: as a result of the investigation, there is no indication of a product quality deficiency.An attempt has been made to obtain missing information; however, to date, no response has been received.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.

Event Description

It was reported that 2 dib00 iol could not deploy properly in the patient eye.Iol came out the wrong way / wrong side.Iol was fully inserted into patient eye and then was removed and replaced.Both iol had the same issue.In the end doctor had to manually load the iol into the patient eye.Patient vision post-operative is 6/15 unaided.No further information available.

• 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: 16975483
• MDR Text Key: 315837740
• Report Number: 3012236936-2023-01294
• Device Sequence Number: 1
• Product Code: HQL
• UDI-Device Identifier: 05050474655386
• UDI-Public: (01)05050474655386(17)250925
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: P980040
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 05/22/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/22/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: DIB00
• Device Catalogue Number: DIB00I0190
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/27/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/25/2022
• 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