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

Model Number DIU150

Device Problems Mechanical Problem (1384); Scratched Material (3020)

Patient Problem Blurred Vision (2137)

Event Date 01/29/2022

Event Type  Injury  

Manufacturer Narrative

If explanted; give date: n/a (not applicable).The lens remains implanted.Telephone number: (b)(6).The intraocular lens (iol) is not returning 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 & johnson surgical vision, inc.Has been submitted.

Event Description

It was initially reported that when using a preloaded intraocular lens (iol), the lens got stuck going through the injector and was subsequently scratched upon implant.The lens remains implanted; however, the surgeon is planning on doing a lens exchange on a later date.No other information was provided.Through follow-up further information was provided clarifying that when the iol stuck in the injector the plunger overrode the lens.Once inserted, a scratch was noted in the middle of optic.Post-implant the patient experienced blurry/distorted vision in the left eye.The patient¿s visual acuity (va) pre-operative (op): best-corrected visual acuity (bcva) 20/50, uncorrected visual acuity (ucva) 20/400, va post-operative: 20/60.The lens exchange is planned for (b)(6) 2022.No other information was provided.

• 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 ; 1700 e st andrew place; santa ana, CA 92705 ; 7142478552
• MDR Report Key: 13984466
• MDR Text Key: 292396702
• Report Number: 3012236936-2022-00776
• Device Sequence Number: 1
• Product Code: MJP
• UDI-Device Identifier: 05050474726499
• UDI-Public: (01)05050474726499(17)240518
• Combination Product (y/n): N
• Reporter Country Code: CA
• 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: 04/01/2022

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?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/18/2024
• Device Model Number: DIU150
• Device Catalogue Number: DIU150I235
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/07/2022
• Initial Date FDA Received: 04/01/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/18/2021
• 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
• Patient Outcome(s): Other
• Patient Sex: Female
• Patient Weight: 75 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White