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

Model Number ZCB00

Device Problem Physical Resistance/Sticking (4012)

Patient Problem Capsular Bag Tear (2639)

Event Date 02/02/2023

Event Type  Injury  

Event Description

It was reported that the haptics of the intraocular lens (iol) were sticking together.The maneuvers required to get the iol open which generated a capsule rupture.An anterior vitrectomy was performed.The patient outcome is unknown.

Manufacturer Narrative

Per regulation eu (b)(4) (general data protection regulation), patient identifiers were not collected or recorded and therefore are not available.Explant date: lens remains implanted.Initial reporter telephone number: (b)(6).The device was not returned for evaluation (lens remains implanted).Therefore, a failure analysis of the complaint device could not 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 and possible product return and evaluation, 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.

• 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: 16482098
• MDR Text Key: 310649991
• Report Number: 3012236936-2023-00278
• Device Sequence Number: 1
• Product Code: HQL
• UDI-Device Identifier: 05050474531772
• UDI-Public: (01)05050474531772(17)260603
• Combination Product (y/n): N
• Reporter Country Code: IT
• 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
• Report Date: 03/03/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/03/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: ZCB00
• Device Catalogue Number: ZCB0000230
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/02/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/03/2022
• 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
• Patient Outcome(s): Required Intervention