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

Model Number DCB00

Device Problem Device Dislodged or Dislocated (2923)

Patient Problems Intraocular Pressure Increased (1937); Vitreous Loss (2142); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Type  Injury  

Manufacturer Narrative

Patient weight: unknown as information was asked but it was not provided.Date of event: unknown/not provided, but the best estimate date is during (b)(6) 2022.Initial reporter telephone number: (b)(6).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.(b)(4).Attempts were made to obtain the missing information; however, no response has been received.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.

Event Description

It was reported that a patient implanted with a one piece preloaded intraocular lens (iol), model dcb00 with 19.0 diopter power, came back the next day for an emergency procedure on the operated eye.Account indicated that the iol superonasally displaced with vitreous in the anterior chamber.A 3-piece lens (model za9003 with 18.5 diopter power) was placed as the replacement iol.Incision enlargement was required, and sutures and vitrectomy were performed.The intraocular pressure (iop) noted as high at the start of the surgery was well controlled post patient discharge.Diamox 250 mg and simbrinza were prescribed by the doctor outside of the normal post-operative treatment.The explanted iol is not available for investigation.No further information received.

Manufacturer Narrative

Corrected data: upon further review the initial mfr report number 3012236936-2022-01922 should have included that the event is both an adverse event and a product problem.Therefore, the current report captures this correction: section b1 - report type: product problem.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.

• Brand Name: TECNIS SIMPLICITY
• 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: 15059161
• MDR Text Key: 296212203
• Report Number: 3012236936-2022-01922
• Device Sequence Number: 1
• Product Code: HQL
• UDI-Device Identifier: 05050474636064
• UDI-Public: (01)05050474636064(17)250216
• 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
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 07/19/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/19/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: DCB00
• Device Catalogue Number: DCB0000190
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/19/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/16/2022
• 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 Age: 76 YR
• Patient Sex: Female
• Patient Ethnicity: Hispanic
• Patient Race: White