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

Model Number DIB00

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

Patient Problem Capsular Bag Tear (2639)

Event Date 09/20/2022

Event Type  Injury  

Event Description

It was reported the patient's ocular dexter (right eye) posterior capsule ruptured and a vitrectomy was performed.The dib00 intraocular lens (iol) was switched to a model z9003 iol.No further information is available.

Manufacturer Narrative

Additional information: catalog number: a complete catalog number is unknown, as device serial number was not provided.Device expiration date: unknown as device serial number was not provided.Udi number: udi number is unknown as device serial number was not provided.Date implanted: not applicable as the iol was not implanted.Date explanted: not applicable as the iol was not implanted.The device was not returned for analysis.Therefore, a visual analysis of the complaint device cannot be completed.In addition, device serial number is not available; therefore, no further investigation can be performed.If there is any further relevant information received, a supplemental medwatch report will be filed.Device manufacture date: unknown as device serial number was not provided.Health effect - (b)(4).All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.

• Brand Name: TECNIS EYHANCE WITH TECNIS SIMPLICITY DELIVERY SYSTEM
• 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: 16065296
• MDR Text Key: 306316491
• Report Number: 3012236936-2022-03187
• Device Sequence Number: 1
• Product Code: HQL
• 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,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/28/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/28/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: DIB00
• Device Catalogue Number: UNK-DIB00
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/08/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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