MAUDE Adverse Event Report: AMO PUERTO RICO MFG. INC. TECNIS IOL; LENS, INTRAOCULAR, TORIC OPTICS

Model Number DIW150

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

Patient Problem Capsular Bag Tear (2639)

Event Date 03/15/2022

Event Type  Injury  

Manufacturer Narrative

Patient information: unknown, information not provided.If explanted, give date: not applicable, lens remains implanted in the eye.Initial reporter number : (b)(6).The intraocular lens (iol) is not returning for evaluation as it remains implanted; 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, no response has been received.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.

Event Description

The account reported posterior capsule rupture on the left eye of a patient.Account provided that the issue was observed when the eye was about to be dialated just after the intraocular lens (iol) was implanted.An unexpected vitreous surgery was performed due to capsule rupture.The surgeon indicated that the leading frosted haptic edge touched the crystalline lens capsule causing the rupture.The uncorrected visual acuity was 0.6 three (3) days after the surgery.The patient is being monitored as it was indicated that there is a possibility of further recovery of the eyesight.No product will be returned as the lens remains implanted in the patient eye.No further information was provided.

Manufacturer Narrative

Additional information: no complaint product was received.A customer provided movie was evaluated by johnson & johnson subject matter expert (sme), who determined that "at minute 5 with 40 seconds and during the intraocular lens (iol) rotation maneuvers to positioning it in the intended axis, the leading haptic appears to be re-folded posteriorly to the lens optic.The surgeon continued with the maneuvers to position the iol axis, which is completed by minute 9 with 17 seconds.At minute 10 with 09 seconds, the surgeon started the limited anterior vitrectomy and completed it by minute 10 with 26 seconds".Furthermore, "it cannot be determined from a video assessment if the frosted haptic edge contributed to a posterior capsule rupture".The complaint issue was not confirmed.Therefore, there is no indication of a product deficiency or product malfunction.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.

• Brand Name: TECNIS IOL
• Type of Device: LENS, INTRAOCULAR, TORIC OPTICS
• 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: 14138886
• MDR Text Key: 292702629
• Report Number: 3012236936-2022-00814
• Device Sequence Number: 1
• Product Code: MJP
• UDI-Device Identifier: 05050474740037
• UDI-Public: (01)05050474740037(17)241105
• 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,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 08/04/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/18/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: DIW150
• Device Catalogue Number: DIW150I190
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/19/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/05/2021
• 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: 72 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: Asian