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

Model Number ICB00

Device Problems Material Fragmentation (1261); Difficult to Insert (1316)

Patient Problems Capsular Bag Tear (2639); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 08/03/2023

Event Type  Injury  

Manufacturer Narrative

Section a2, a4 and a5: unknown/ not provided.Patient information cannot be provided due to personal data privacy legislation/policy section d6a: implant date: not applicable, as lens was removed in the initial surgery.Section d6b: explant date: not applicable, as lens was removed in the initial surgery.Section e1: initial reporter first name: unknown/not provided, as information was asked but it was not provided.Section e1: email address: unknown/not provided, as information was asked but it was not provided.Section e1: initial reporter telephone number: (b)(6).Section h3-other (81): the device was not returned for evaluation; 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.Section h6- health effect - clinical code 4581: no code available (incision enlarged) all pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.

Event Description

It was reported that during intraocular lens (iol) implantation surgery, when the iol was injected into the patient eye, the capsule bag was ruptured and the lens could not be placed / fixed into position.Hence, the iol was removed from the patient's operative eye.After the iol was removed, the haptic was noted to be detached and missing.After searching in the eye, the haptic could not be found.There was no patient injury reported after the surgery.However, the incision was enlarged and sutures were required.There was a delay to the overall surgery time.No further information was provided.

Manufacturer Narrative

Section d9: device available for evaluation: yes date returned to manufacturer: 18 aug 2023 section h3: device evaluated by manufacturer: yes device evaluation: visual inspection under magnification revealed that the complaint lens was received with a haptic detached.The lens was cleaned and, scratches could be observed on the optic body as well.The remaining haptic was dimensionally inspected, revealing that the haptic was within specification.No further product evaluation could be performed.Dimensional inspection was performed on the remaining haptic confirming that the haptic width and haptic thickness were manufactured within specification.The complaint issue could not be confirmed to be related to the manufacturing or design process.Manufacturing record evaluation: based on the manufacturing records review, and historical complaint review, there is no indication of a product malfunction or product quality deficiency.No nonconformity report, documentation or labeling changes, and escalations are required.Conclusion: as a result of the investigation, there is no indication of a product quality deficiency.All pertinent information available to johnson & 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: 17628009
• MDR Text Key: 322019637
• Report Number: 3012236936-2023-02166
• Device Sequence Number: 1
• Product Code: HQL
• UDI-Device Identifier: 05050474610798
• UDI-Public: (01)05050474610798(17)280209
• Combination Product (y/n): N
• Reporter Country Code: HK
• 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: Nurse
• Type of Report: Initial,Followup
• Report Date: 11/06/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: ICB00
• Device Catalogue Number: ICB00I0220
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 08/03/2023
• Initial Date FDA Received: 08/25/2023
• Supplement Dates Manufacturer Received: 10/12/2023
• Supplement Dates FDA Received: 11/06/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/09/2023
• 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