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

Model Number DIU225I090

Device Problems Break (1069); Mechanical Jam (2983)

Patient Problem Corneal Edema (1791)

Event Type  Injury  

Manufacturer Narrative

Per regulation eu 2016/679 (general data protection regulation), patient identifiers were not collected or recorded and therefore are not available.Initial reporter telephone number: (b)(6).The intraocular lens (iol) was not returned for evaluation.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.Attempts have been made to obtain missing information.However, to date, no response has been received.All pertinent information available to johnson and johnson surgical vision, inc.Has been submitted.

Event Description

It was reported that the intraocular lens (iol) was stuck in the introducer and came out cracked and upside-down.There was no replacement lens on hand and it was determined that an iol exchange would be required for the patient.Through follow-up it was explained that the lens was stuck in the introducer and difficult to expel, but the account was unsure if the lens was upside down in the cartridge or cracked pre-insertion.The customer believed there was poor capture of the introducer tip with the lens inside the cartridge.The lens was fully inserted into the eye, because the patient is a pathological young high myope with high risk of retinal detachment if left aphakic.The lens was distorted prior to unfolding, with clear damage to the optic.It was also evident that the haptics were in a ¿s¿ type configuration.The lens did, however, unfold without causing intraocular damage.After unfolding in the bag it was clear that the lens had numerous cracks within the visual axis.The patient did well postoperatively and had an uncorrected visual acuity of 6/24 which was still better than prior to surgery.The patient was counseled postoperatively and was scheduled for an iol exchange 2 weeks post her cataract surgery.The patient understood and was happy with the decision.The damaged iol was removed without complications and the new iol inserted within the bag.Postoperatively the patient had corneal edema.She is currently recovering and i expect a good result.The surgeon confirmed that if they had a backup iol in the theatre the damaged lens would not have been implanted and that the patient would not have needed a second surgery.No further details were 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 ; 31 technology drive; irvine, CA 92618 ; 7142478552
• MDR Report Key: 15307768
• MDR Text Key: 298770557
• Report Number: 3012236936-2022-02204
• Device Sequence Number: 1
• Product Code: MJP
• UDI-Device Identifier: 05050474726796
• UDI-Public: (01)05050474726796(17)250423
• Combination Product (y/n): N
• Reporter Country Code: SF
• PMA/PMN Number: P980040
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 08/27/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/28/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: DIU225I090
• Device Catalogue Number: DIU225I090
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/03/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/23/2022
• 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