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

Model Number DIB00

Device Problems Break (1069); Difficult to Fold, Unfold or Collapse (1254)

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

Event Date 12/02/2022

Event Type  malfunction  

Event Description

It was reported that as the intraocular lens (iol) was being implanted the trailing haptic was almost stuck to the injector and was not folded into the optic body.Appeared to have a kink in the haptic and was sticking out of the wound.The surgeon felt the issue was not of significant concern and left the iol implanted.Reportedly, this was unusual.There was no vitrectomy, sutures or incision enlargement.No further information was provided.

Manufacturer Narrative

If explanted, give date: not applicable as the iol remains implanted.The device was not returned 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 the missing information.However, to date it has not been received.All pertinent information available to johnson & johnson surgical vision, inc., has been submitted.

Manufacturer Narrative

Device evaluation: the video provided by the customer was evaluated.A 34 second video showing the intraocular lens implantation of an iol claimed to be a tecnis eyhance iol with simplicity delivery system model dib00 it can be observed during iol insertion and facing difficulties to release the trailing haptic from the delivery system at seconds 8 and 11 in which the plunger rode seems overriding the trailing haptic.At second 13 the trailing haptic is released unfolded and twisted/crimped.It is observed that the haptic was positioned in the capsular bag ending with a lens implanted in capsular bag and centered at second 34.The actual root cause and the potential final clinical impact for the reported incident cannot be determined from a video assessment.A product quality deficiency could not be determined.Conclusion: as a result of the investigation there is no indication of a product quality deficiency, and the reported issue could not be verified.All pertinent information available to johnson & johnson surgical vision, inc., has been submitted.

• 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: 16038866
• MDR Text Key: 308258588
• Report Number: 3012236936-2022-03046
• 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,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 02/09/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/22/2022
• 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: DIB00U0230
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/18/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/06/2022
• 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