MAUDE Adverse Event Report: AMO PUERTO RICO MFG. INC. TECNIS 1-PIECE IOL WITH TECNIS SIMPLICITY DELIVERY SYSTEM; INTRAOCULAR LENS

Model Number	DCB00
Medical Device Problem Codes	Break (1069); Material Too Rigid or Stiff (1544)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/07/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Explant date: lens remains implanted; therefore, not explanted.(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, labeling, 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 or Problem Description
It was reported that the preloaded intraocular lens(iol) device was difficult to push through while setting-up the unit.Account provided that it was stiff and a little pressure had to be applied to the device that was filled with balanced saline solution (bss) and topped-off with protectalon 1.4% viscoelastic solution.Advancing the device during the insertion step was initially less stiff than the preparation; however, it became stiffer towards the end resulting in the lens being slightly crumpled and turned a quarter turn as well as leaving plunger marks (2 tooth marks) on the optic.The lens remains implanted.No intervention has been planned.No additional information was provided.

• Brand Name: TECNIS 1-PIECE IOL WITH TECNIS SIMPLICITY DELIVERY SYSTEM
• Common Device Name: INTRAOCULAR LENS
• Manufacturer (Section D): AMO PUERTO RICO MFG. INC.; road 402 north, anasco ind. pk; anasco PR 00610
• MDR Report Key: 12708746
• Report Number: 2020664-2021-07806
• Device Sequence Number: 17203396
• Product Code: HQL
• UDI-Device Identifier: 05050474635944
• UDI-Public: (01)05050474635944(17)231109
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• PMA/510(K) Number: P980040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 10/27/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 11/09/2023
• Device Model Number: DCB00
• Device Catalogue Number: DCB0000130
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/07/2021
• Initial Report FDA Received Date: 10/27/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1