MAUDE Adverse Event Report: AMO PUERTO RICO MFG. INC. SENSAR IOL; INTRAOCULAR LENS

Model Number	AR40E
Medical Device Problem Codes	Material Fragmentation (1261); Device Difficult to Setup or Prepare (1487)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/20/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Age, weight, and ethnicity: unknown/ not provided.If implanted, give date: as lens was removed/replaced during the same procedure.If explanted, give date: as lens was removed/replaced during the same procedure.Last name: unknown/not provided.The device is not returning for evaluation as it was discarded by the account; therefore, a failure analysis of the complaint device cannot be completed.A review of the device/lot history record and complaint trending 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 or Problem Description
It was reported that the intraocular lens (iol) had trailing haptic ripped after implantation and explant was performed.It was stated that the iol was extremely rigid and very difficult to load correctly through emerald cartridge/inserter.There was patient contact.The suspect product was discarded.No further information was provided.
Additional Manufacturer Narrative
Additional information: upon further follow-up information received that patient is male, lebanese, 210 lbs., 55 yrs.Old, date of birth (b)(6) 1966.And that patient is doing good now.No other information was provided.The following sections are updated: section a2: 55 yrs.Old; date of birth: (b)(6) 1966.Section a3: gender: male section a4: weight: 210 lbs.Section a5: ethnicity: white all pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.

• Brand Name: SENSAR IOL
• 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: 11341268
• Report Number: 2648035-2021-07283
• Device Sequence Number: 16981118
• Product Code: HQL
• UDI-Device Identifier: 05050474514089
• UDI-Public: (01)05050474514089(17)250917
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: P980040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/12/2021

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: 09/17/2025
• Device Model Number: AR40E
• Device Catalogue Number: AR40E00045
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 01/20/2021
• Supplement Date Received by Manufacturer: 03/18/2021
• Initial Report FDA Received Date: 02/17/2021
• Supplement Report FDA Received Date: 04/12/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: EMERALD C30 CARTRIDGE
• Patient Age: 55 YR
• Patient Weight: 95