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

Model Number DIB00

Device Problem Physical Resistance/Sticking (4012)

Patient Problems Visual Disturbances (2140); No Clinical Signs, Symptoms or Conditions (4582)

Event Type  Injury  

Manufacturer Narrative

Date explanted: not applicable as the iol remains implanted.It was indicated that the iol is not being returned for evaluation as it remains implanted in the patient¿s eye.Therefore, a visual analysis of the complaint device cannot be completed.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.Section h-4 device manufacture date: unknown, as device serial number was not provided.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.

Event Description

It was reported the surgeon had haptic issues while using pre-loaded dib00 intraocular lens (iol).Based on the video provided the haptics are stuck to each other.A secondary corneal incision port was created.Patient had maddox rod effect which was resolved in a week after the capsule did its shrink wrapping.There is no indication the iol was removed.No further information is available.

Manufacturer Narrative

Additional information: device evaluation: two brief videos (19 and 20 seconds) showing the late phase of implantation of an intraocular lens claimed to be a tecnis enhance simplicity model dib00.It is observed in both videos the haptics attached between them (haptic stick to haptic); it is also observed maneuvers attempting to release the haptics.The videos do not show the outcome/haptic status.A definitive root cause and the potential clinical impact of the reported observation cannot be determined from a video assessment.Complaint issue "haptic stuck to haptic" was identified during video evaluation; however, based on the complaint investigation results the complaint issue could not be confirmed to be related to the manufacturing or design process.Conclusion: based on the investigation results, there is no indication of a product malfunction or product quality deficiency.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: 16162762
• MDR Text Key: 307464760
• Report Number: 3012236936-2023-00103
• Device Sequence Number: 1
• Product Code: HQL
• UDI-Public: (01)
• 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,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 02/27/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/13/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• 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: 02/03/2023
• 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