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

Model Number DIU100

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Visual Impairment (2138)

Event Date 05/02/2022

Event Type  Injury  

Manufacturer Narrative

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.If explanted, give date: not applicable, as lens the lens was repositioned and remains implanted in the eye.Telephone number: (b)(6).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.All pertinent information available to johnson and johnson surgical vision, inc.Has been submitted.

Event Description

It was reported that the postoperative refraction of approximately -2.00 diopters after the implantation of an tecnis eyhance toric intraocular lens (iol) was incorrect.Through follow-up, we learned that the patient was calculated for emmetropia.The patient's visual symptoms were described as unclear vision.The patient's vision was -2,25 spherical -1.25 cylinder 105° axis.No prescription outside of normal postoperative care was given.The patient's condition significantly interfered with the patient's ability to drive and work.The planned position before implantation was 79° and the iol was in the desired axis of 79° during the post-operative (op) monitoring.An exploratory iol reposition was carried out on the (b)(6) 2022.After the reposition, on (b)(6) 2022, the patient¿s refraction was -1,25 spherical -0,50 cylinder 11°axis.No further information was reported.

Manufacturer Narrative

Corrected information: upon further review, it was noted that in the initial mdr report number 3012236936-2022-02255 that the patient's gender is female in section a3 gender was inadvertently not included.Therefore, it is captured in this supplemental report.The following section has been updated accordingly: section a3: gender: female.All pertinent information available to johnson and johnson surgical vision, inc.Has been submitted.

• Brand Name: TECNIS IOL
• Type of Device: LENS, INTRAOCULAR, TORIC OPTICS
• 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: 15331820
• MDR Text Key: 299043242
• Report Number: 3012236936-2022-02255
• Device Sequence Number: 1
• Product Code: MJP
• UDI-Device Identifier: 05050474725867
• UDI-Public: (01)05050474725867(17)250118
• Combination Product (y/n): N
• Reporter Country Code: GM
• 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: 09/26/2022

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?: No
• Device Operator: Health Professional
• Device Model Number: DIU100
• Device Catalogue Number: DIU100I215
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 08/01/2022
• Initial Date FDA Received: 08/31/2022
• Supplement Dates Manufacturer Received: 09/01/2022
• Supplement Dates FDA Received: 09/27/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/18/2022
• 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
• Patient Sex: Female