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

Model Number DCB00

Device Problem Difficult to Insert (1316)

Patient Problems Hyphema (1911); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 06/14/2021

Event Type  Injury  

Manufacturer Narrative

Additional information: ethnicity and race: information not available as account does not document this information in the patient's chart.Date implanted: not applicable, as the iol was removed/replaced during the same procedure.Date explanted: not applicable, as the iol was removed/replaced during the same procedure.Device evaluated by mfr: the device was not returned for analysis as the product was discarded therefore, a failure analysis of the complaint device cannot be completed.A review of the device/lot history record and historical data analysis for this device will be performed.Upon completion of the review, if there is any further relevant information a supplemental medwatch report will be filed.(b)(4).All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.

Event Description

It was reported that the intraocular lens (iol) was placed in the patient's ocular dexter (right eye) and removed during the same procedure due to the iol sitting vertically and not sitting correctly.Hemorrhage occurred and stitches were required.A non-johnson & johnson surgical vision anterior chamber lens was implanted and the patient had to return the next day for an anterior chamber wash-out procedure.The lens is not being returned as it was discarded.Patient outcome post-procedure was reported as stable condition.Through follow-up, additional information was received confirming no serious patient injury.However, unplanned incision enlargement and unplanned vitrectomy were performed.Reported hemorrhage was clarified as hyphema.No further information is 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 ; road 402 north, anasco ind. pk; anasco, PR 00610 ; 7142478552
• MDR Report Key: 12194130
• MDR Text Key: 263436410
• Report Number: 2648035-2021-08082
• Device Sequence Number: 1
• Product Code: HQL
• UDI-Device Identifier: 05050474636156
• UDI-Public: (01)05050474636156(17)240208
• 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 faci
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 07/19/2021

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?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/08/2024
• Device Model Number: DCB00
• Device Catalogue Number: DCB0000235
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 06/21/2021
• Initial Date FDA Received: 07/19/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/08/2021
• 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 Age: 81 YR
• Patient Weight: 62