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

Model Number ICB00

Device Problems Difficult to Fold, Unfold or Collapse (1254); Physical Resistance/Sticking (4012)

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

Event Date 04/19/2023

Event Type  malfunction  

Event Description

It was reported that the intraocular lens (iol) was unfolding slowly and that the haptics were sticking together.The directions for use (dfu) where followed and the product was stored in the operation room (or).The patient outcome is unknown.No further information was provided.

Manufacturer Narrative

Section a2, a4 and a5: information unknown/ not provided.Per regulation eu 2016/679 (general data protection regulation), patient identifiers were not collected or recorded and therefore are not available.Section d6b - explant date: not applicable, lens remains implanted.Section e1 - telephone number: (b)(6).Section h3 - other (81): the intraocular lens (iol) 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.All pertinent information available to johnson and johnson surgical vision, inc.Has been submitted.

Manufacturer Narrative

Additional information: section h3 - device evaluated by manufacturer? yes.Device evaluation: the customer provided a video displaying the implantation of an intraocular lens (iol) claiming to be an icb00 tecnis eyhance.The implantation of the lens occurs at time stamp 0:07.The iol unfolds partially and is moved into place within the patient's eye.At time stamp 0:25, manipulation of the lens with surgical implements begins.The implements release the haptics from the optic body and the video ends at 0:41.The iol is not displayed as fully unfolded when the video ends.Per specifications, the haptics of the lens are to unfold in less than 34 seconds and the lens is to be flat in less than 60 seconds.While the haptics of the complaint lens were observed to be together it cannot be confirmed that the haptic unfolding was out of specification as 34 seconds had not elapsed before the haptics were manually detached.The unfolding of the iol cannot be determined to be out of specification as well as the video ends before the specification time of 60 seconds.The complaint issue of haptic stuck to haptic and unfolding issue could not be confirmed during product evaluation.Conclusion: as a result of the investigation, there is no indication of a product quality deficiency.All pertinent information available to johnson and johnson surgical vision, inc.Has been submitted.

• Brand Name: TECNIS IOL
• 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: 16906749
• MDR Text Key: 314951334
• Report Number: 3012236936-2023-01105
• Device Sequence Number: 1
• Product Code: HQL
• UDI-Device Identifier: 05050474610613
• UDI-Public: (01)05050474610613(17)260910
• Combination Product (y/n): N
• Reporter Country Code: NL
• 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: 08/03/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/10/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: ICB00
• Device Catalogue Number: ICB00I0130
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/28/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/10/2021
• 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